Written and maintained by CASRAI Editorial Board
Last updated
General product information for laboratory, clinic and supply staff. It is not medical advice and does not describe how to perform a procedure.
Short answer
A rigid cystoscope is built from a sheath, an obturator and an optical lens (telescope), joined by a bridge that also carries a working channel. A flexible cystoscope is a single steerable instrument with its own working channel and a camera chip at the tip. In the United States, both sit under FDA product code FAJ and 21 CFR 876.1500.
Definition and scope
“Cystoscope parts” means the components of an endoscope used to look inside the bladder and urethra. FDA’s product classification database lists code FAJ as “cystoscope and accessories, flexible/rigid”, a Class 2 device under regulation 876.1500, used to examine and perform procedures within the urinary tract. The regulation describes an endoscope as a device that provides access, illumination and observation or manipulation of body cavities, and names diagnostic cystoscopes and cystourethroscopes among the examples.
This page covers the parts of the instrument itself. The irrigation set is a separate device, covered in cystoscopy tubing. For endoscopes in general, see what an endoscope is.
The main parts and what each one does
The Urology Textbook chapter on cystoscopy describes the two instrument types in these terms. Part names vary between manufacturers; the labels below follow the textbook’s wording.
Cystoscope sheath
The sheath is the outer tube of a rigid cystoscope. The textbook gives its calibre as 17 to 22 CH. CH (Charriere) is the same unit that many catalogues write as Fr or French, so a sheath listed in either unit is described on one scale.
Obturator
The obturator fits inside the sheath and blunts it. The textbook lists it as one of the three core rigid components.
Optical lens (telescope)
The optical lens carries the image. It comes with different tip angles: 0 degrees for the urethra, and 30 or 70 degrees for the bladder, per the textbook. Some manufacturers call this component the telescope.
Bridge and working channel
The bridge connects the lens to the sheath and provides a working channel through which forceps, wires or ureteral stents can be passed. The working channel is therefore an attribute of the assembled instrument.
Flexible cystoscope
The textbook gives a flexible cystoscope diameter of 16 to 20 CH, an actively steerable distal end, a working channel of up to 8 CH, and a camera chip (CCD sensor) on the tip rather than fibre optics.
Rigid and flexible cystoscope parts compared
| Feature | Rigid cystoscope | Flexible cystoscope |
|---|---|---|
| Outer tube | Sheath, 17-22 CH | Single shaft, 16-20 CH |
| Blunting piece | Obturator | Not listed as a separate part |
| Imaging | Optical lens with 0, 30 or 70 degree tip angles | Camera chip (CCD sensor) on the tip |
| Channel | Working channel through the bridge | Working channel, up to 8 CH |
| Tip control | Not described | Actively steerable distal end |
Source for every row: Urology Textbook, “Cystoscopy” (checked 2026-10-31).
Where it matters for labs, clinics and supply decisions
Regulatory class of the instrument and its accessories
21 CFR 876.1500 sorts endoscope accessories into different exemption groups, which is useful when a catalogue mixes instruments and add-ons. As set out in the regulation text (checked 2026-10-31):
- Class II, exempt from premarket notification subject to 21 CFR 876.9: sterile scissors for cystoscope intended for single use, endoscope disinfectant basins, LED and other listed light sources, and endoscope transformers.
- Class I, exempt subject to the same limitations: cleaning brushes for endoscopes, bite blocks, inflation bulbs, rechargeable and pocket battery boxes, binocular attachments, and photographic accessories.
The cystoscope itself is not in these exempt lists. FDA’s classification entry for FAJ notes that reusable flexible endoscopes in this code require validated reprocessing instructions and reprocessing validation data in a 510(k) submission.
A terminology cross-check for comparing listings
Because naming varies, a short cross-check helps when you compare documents from different sources. These are matching aids for reading documents.
- Sheath calibre: confirm whether the unit is CH or Fr (the textbook uses CH).
- Lens: confirm whether the listing means the optical lens or telescope, and which tip angle it carries.
- Bridge: check whether the working channel belongs to the bridge or to the sheath in that manufacturer’s description.
- Rigid or flexible: the two follow different part lists, as shown in the table above.
- Reuse status: the product’s own instructions for use state how it is cleaned and reprocessed.
Common misunderstandings
- “Cystoscope” always means one fixed set of parts. Rigid and flexible instruments differ, and the textbook lists different components for each.
- The sheath size is the whole instrument’s size. The sheath is one part of a rigid instrument; the flexible type has a single shaft.
- Accessories share the instrument’s class. Under 21 CFR 876.1500, many accessories are listed as Class I or Class II exempt, as set out above.
- A cystoscope and a ureteroscope are the same tool. They are different devices; see cystoscope vs ureteroscope and the semi-rigid ureteroscope guide.
FAQ
What are the parts of a cystoscope?
A rigid cystoscope consists of a sheath, an obturator and an optical lens, with a bridge connecting the lens to the sheath and providing a working channel. A flexible cystoscope is one steerable instrument with a working channel and a tip camera chip (Urology Textbook, checked 2026-10-31).
What is a cystoscope sheath?
It is the outer tube of a rigid cystoscope, given as 17 to 22 CH by the Urology Textbook. The obturator and the lens assembly are used with it.
What sizes do cystoscopes come in?
The textbook gives 17 to 22 CH for rigid sheaths and 16 to 20 CH for flexible instruments, with a flexible working channel up to 8 CH. CH is Charriere, also written Fr. Exact sizes depend on the manufacturer and model, so read the product’s own documentation.
Which FDA code covers cystoscopes?
Product code FAJ, “cystoscope and accessories, flexible/rigid”, Class 2, regulation 21 CFR 876.1500 (FDA classification database, checked 2026-10-31).
Sources
- U.S. FDA, Product Classification database, code FAJ, accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=FAJ. Checked 2026-10-31.
- 21 CFR 876.1500, Endoscope and accessories, ecfr.gov/current/title-21/section-876.1500. Checked 2026-10-31.
- Urology Textbook, “Cystoscopy”, urology-textbook.com/cystoscopy.html. Secondary source (textbook), checked 2026-10-31.
