Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
On this page
Who uses this: clinic and operating-room staff, sterile processing teams, buyers reading a quote or catalog, and students learning the vocabulary. After reading you should be able to name the general-purpose hand instruments the FDA lists, tell which regulation an instrument falls under, and read an instrument name on a supplier document.
What counts as a general surgical instrument
In United States regulation, the FDA defines a “manual surgical instrument for general use” as a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures (21 CFR 878.4800). That definition is the closest thing to an official list of surgical tool names, and it is the list used below. Terms such as “surgical tools” and “medical tools” are everyday wording for the same family; the regulation uses “instrument” and “device”.
The FDA’s list of general-use instrument names
The regulation names the following devices. The grouping in the left column is an editorial convenience for reading, not the FDA’s; the names in the right column are the FDA’s own words.
| Reading group (editorial) | Names in 21 CFR 878.4800 |
|---|---|
| Cutting | knife, scalpel blade, scalpel handle, one-piece scalpel, cutter, chisel, gouge, osteotome, saw, snare |
| Grasping and clamping | forceps, clamp, hemostat, pliers, clip applier, ligature carrier, ligature passing and knot-tying instrument |
| Retracting and exposing | retractor, contractor, elevator, dissector, spatula, amputation hook, skin graft expander |
| Scraping, smoothing and striking | curette, file, rasp, stripper, hammer, mallet |
| Suturing, stapling and needles | stapler, suturing needle (disposable or reusable), aspiration and injection needle (disposable or reusable), suturing apparatus for the stomach and intestine |
| Guides, probes and measuring | instrument guide, needle guide, stylet, measuring tape, calipers, retainer |
| Applicators and brushes | applicator, cannula, biopsy brush, manual dermabrasion brush, scrub brush |
Source: 21 CFR 878.4800(a), checked 2026-11-02 at https://www.law.cornell.edu/cfr/text/21/878.4800 (the same text as the eCFR).
Detail pages for individual instruments
For one instrument family at a time, see our pages on surgical blade types, surgical scissors types, surgical retractors, and the comparison of Crile and Kelly forceps. For specialty sets, see urology instruments.
Specialty instruments are classified elsewhere
The same regulation states that a surgical instrument with specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of Title 21. So the same everyday name can sit under different regulations depending on the instrument. The FDA’s classification database (openFDA, checked 2026-11-02) shows this for retractors, hemostats and clamps:
| FDA product name | Class | Regulation or panel |
|---|---|---|
| Retractor (code GAD) | 1 | 21 CFR 878.4800, General and Plastic Surgery |
| Hemostat (code HRQ) | 1 | 21 CFR 878.4800, General and Plastic Surgery |
| Retractor, Self-Retaining (code FFO) | 1 | 21 CFR 876.4730, Gastroenterology and Urology |
| Retractor, Self-Retaining, For Neurosurgery (code GZT) | 2 | 21 CFR 882.4800, Neurology |
| Clamp, Vascular (code DXC) | 2 | 21 CFR 870.4450, Cardiovascular |
Source: openFDA device classification, https://api.fda.gov/device/classification.json, checked 2026-11-02.
What Class I exempt means on a supplier document
General-use manual surgical instruments are Class I (general controls) and are exempt from the premarket notification (510(k)) procedures in subpart E of part 807, subject to the limitations in 21 CFR 878.9. This describes the regulatory category of the device type; it says nothing about the quality of any particular maker, and it does not apply to the Class 2 specialty instruments above.
How to read an instrument name on a quote or catalog
- Base name first. Match the noun (forceps, retractor, scissors) to the FDA terms above to see whether it is a general-use instrument or a specialty one.
- Pattern details differ between makers. The same label can describe slightly different instruments, for example in serration pattern or length, so compare catalog numbers and dimensions rather than the name alone. The Crile versus Kelly comparison sets this out.
- Reusable or disposable. The FDA definition covers both. The manufacturer’s labeling states which applies.
- Size and length. Take them from the manufacturer’s listing; they are not part of the FDA definition.
Handling and reprocessing basics
The CDC’s Rational Approach to Disinfection and Sterilization places surgical instruments in the “critical” category: items that confer a high risk of infection if contaminated with any microorganism, because they enter sterile tissue or the vascular system. The CDC states that most items in this category should be purchased sterile or be sterilized with steam if possible. It also notes that liquid chemical sterilants reliably produce sterility only if cleaning precedes treatment. Follow each manufacturer’s instructions for use for the specific instrument; see also our guide to cleaning and sterilizing surgical instruments.
Common mistakes
- Treating a name as a specification: the same name can cover different serration, length or pattern between makers.
- Assuming every instrument sits under the general-use regulation: specialty instruments are classified in parts 868 through 892.
- Reading Class I exempt as a statement about product quality; it is a regulatory category.
Surgical tool names and medical tools names
Searches for “surgical tool names and pictures” and “medical tools names” are answered by the same vocabulary: the FDA list above covers general hand instruments, while other medical tools are classified in other parts of Title 21. This page lists names and regulatory categories in words.
Frequently asked questions
What are the names of common surgical instruments?
The FDA’s list of general-use manual instruments includes forceps, clamps, hemostats, retractors, scalpel blades and handles, curettes, elevators, dissectors, staplers, suturing needles, cannulas and calipers; the full list is in the table above.
Are surgical tools and medical tools the same thing?
“Surgical tools” is everyday wording for surgical instruments. “Medical tools” is broader; devices outside the general-use surgical list are classified in other parts of Title 21.
Does Class I exempt mean an instrument is better?
No. It names a regulatory category: general controls apply and the device type is exempt from premarket notification, subject to the limitations in 21 CFR 878.9.
Are surgical instruments sterile?
The CDC places surgical instruments in the critical category and states that most items in it should be purchased sterile or be sterilized with steam if possible. The manufacturer’s instructions for use apply to each instrument.
Sources
All sources checked 2026-11-02.
- 21 CFR 878.4800, Manual surgical instrument for general use: https://www.law.cornell.edu/cfr/text/21/878.4800
- FDA openFDA device classification database: https://api.fda.gov/device/classification.json
- CDC, A Rational Approach to Disinfection and Sterilization: https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/rational-approach.html
