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Urology instruments are the endoscopes, dilators, cutting tools and hand-held surgical instruments used to examine and treat the urinary tract. In US regulation they are not one category: FDA places them in several device groups under 21 CFR Part 876, each with its own class. This page maps those groups so clinic staff, buyers and students can match an instrument name to a regulation number, a class and a product code.
This page describes products and general use; it is not medical advice.
Who uses these instruments: urologists and clinic or operating-room teams use them; sterile processing staff reprocess them; buyers and students look them up by name and class.
What urology instruments are
In the CFR, an endoscope and its accessories is “a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.” The same section names diagnostic cystoscopes, cystourethroscopes, resectoscopes, nephroscopes, ureteroscopes and urethroscopes as examples (21 CFR 876.1500). Hand-held instruments sit in a separate group, and dilators and urethrotomes each have their own regulation.
How FDA groups urology instruments
The table below follows the regulations themselves. “Exempt” means exempt from 510(k) premarket notification, subject to the limits in 21 CFR 876.9.
| Group | Examples named in the regulation | 21 CFR | Class |
|---|---|---|---|
| Endoscopes and accessories | Cystoscopes, cystourethroscopes, resectoscopes, nephroscopes, ureteroscopes, urethroscopes, cytology brushes | 876.1500 | Class II for the endoscopes; some accessories Class I |
| Endoscopic electrosurgical unit and accessories | Generator, electric biopsy forceps, electrode, flexible snare, patient plate, adaptor to the cord for transurethral surgical instruments, transurethral desiccator | 876.4300 | Class II |
| Manual gastroenterology-urology surgical instruments | Needle holder, clamps, hook, probe and director, retractors, nonelectrical snare, bladder neck spreader, scoop | 876.4730 | Class I, exempt |
| Urethrotome | Metal instrument with a dorsal-fin cutting blade that can be elevated from its sheath; some have an optical channel | 876.4770 | Class II, exempt |
| Urethral dilators | Mechanical urethral dilator, urological bougies, urethral sounds, urethrometer, filiform and follower | 876.5520 | Class II; bougie, filiform and follower, sound and urethrometer are Class I, exempt |
Endoscopes and accessories
Section 876.1500 is the widest group. Within it, FDA separates accessories by risk. Class II (special controls, exempt from 510(k) subject to 876.9) includes sterile scissors for cystoscope intended for single use, disposable non-powered endoscopic grasping or cutting instruments for single use, genitourinary endoscopic guidewires, endoscope disinfectant basins and several light sources. Class I covers items such as the bite block, the inflation bulb, the smoke removal tube and the cleaning brush for endoscope.
openFDA lists these product codes under 876.1500, all Class 2: FAJ (cystoscope and accessories, flexible or rigid), KGD (scissors for cystoscope), FJL (resectoscope), FDC (resectoscope, working element) and FGB (ureteroscope and accessories, flexible or rigid). For part-by-part detail see cystoscope parts and the semi-rigid ureteroscope; for accessories see endoscopic biopsy forceps, stone baskets and the JJ stent.
Urethral dilators, sounds and bougies
Under 21 CFR 876.5520 a urethral dilator is a slender hollow or solid instrument made “in a range of sizes and flexibilities.” The generic type covers mechanical dilators, urological bougies, metal or plastic urethral sounds, the urethrometer, filiforms and filiform followers. In openFDA, product code FBX (sound, urethral, metal or plastic) is Class 1, while FAH (dilator, urethral, mechanical) and KOE (dilator, urethral) are Class 2. The urethral dilator guide covers the types in more detail.
Cutting and manual instruments
The urethrotome is defined in 876.4770 as a metal instrument with a dorsal-fin cutting blade that can be raised from its sheath,; openFDA lists it as product code EZO, Class 2. Hand-held instruments such as needle holders, clamps and retractors fall under 876.4730, which covers devices that are “nonpowered, hand-held, or hand-manipulated.” Mesh insertion aids for urogynecologic procedures are regulated separately under 21 CFR 884.4910.
What a urology instrument set is
A “urology instrument set” is a purchasing and listing term, not a regulatory one. The regulations above define device groups, not set contents, so two listings with the same name can include different items. Compare a set against the group list in 876.4730 and the endoscope accessories in 876.1500, and see custom procedure trays for how FDA treats trays. Disposables used around cystoscopy are covered in the cystoscopy drape, cystoscopy tubing and urology clinic supply checklist guides.
Cleaning and reprocessing basics
FDA’s reprocessing guidance (issued March 17, 2015) sorts reusable devices into categories by what they contact: critical devices contact a normally sterile tissue or body space, and semi-critical devices contact intact mucous membranes. The guidance gives surgical instruments and endoscope biopsy accessories as examples of critical devices. These are nonbinding recommendations, and the manufacturer’s instructions for use govern a specific device. For endoscope care, see endoscope leak test.
What to ask a supplier
- The device’s FDA product code and 21 CFR regulation number, so it can be matched to the table above and to the openFDA classification record.
- The manufacturer’s instructions for use, including the reprocessing instructions for a reusable instrument.
- Whether the item is labeled single use or reusable; several Class II accessories in 876.1500 are defined as single use.
Common mistakes
- Treating “urology instruments” as one FDA class. Class ranges from I to II across the groups above.
- Assuming a set name tells you its contents.
- Applying one reprocessing method to every item; the guidance distinguishes critical and semi-critical devices and defers to the IFU.
FAQ
What are the main types of urology instruments?
Endoscopes and their accessories (876.1500), electrosurgical accessories (876.4300), manual surgical instruments (876.4730), urethrotomes (876.4770) and urethral dilators, sounds and bougies (876.5520).
Are urology instruments Class I or Class II?
Both. Manual instruments under 876.4730 are Class I; endoscopes, resectoscopes, ureteroscopes and urethrotomes are Class II; dilators are Class II with several Class I exempt types.
What is in a urology instrument set?
No regulation defines it. Set contents are set by the seller or the facility, so check the item list against the device groups above.
Sources
Checked on 2026-11-01.
- 21 CFR 876.1500, Endoscope and accessories: https://www.law.cornell.edu/cfr/text/21/876.1500 (checked 2026-11-01)
- 21 CFR 876.4300, Endoscopic electrosurgical unit and accessories: https://www.law.cornell.edu/cfr/text/21/876.4300 (checked 2026-11-01)
- 21 CFR 876.4730, Manual gastroenterology-urology surgical instrument and accessories: https://www.law.cornell.edu/cfr/text/21/876.4730 (checked 2026-11-01)
- 21 CFR 876.4770, Urethrotome: https://www.law.cornell.edu/cfr/text/21/876.4770 (checked 2026-11-01)
- 21 CFR 876.5520, Urethral dilator: https://www.law.cornell.edu/cfr/text/21/876.5520 (checked 2026-11-01)
- openFDA device classification API: https://api.fda.gov/device/classification.json (checked 2026-11-01)
- FDA, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015): https://www.fda.gov/media/80265/download (checked 2026-11-01)
