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General product and regulatory information only; this is not medical advice and does not describe how any clamp is used on a patient.
A surgical clamp is a hand-operated instrument that holds, compresses or occludes tissue or a vessel, and the US Food and Drug Administration does not treat all clamps as one device type. In the Code of Federal Regulations a general-use clamp is a Class I device, while a vascular clamp, an umbilical clamp and a circumcision clamp are Class II. This page sorts clamp types by the regulation that names them, with classes checked against the CFR and the openFDA device classification database on 2026-10-30.
What counts as a surgical clamp
Under 21 CFR 878.4800, a manual surgical instrument for general use is “a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.” The same list names “clamp”, “forceps” and “hemostat” as separate items, which is one reason catalogs disagree about where a clamp ends and a hemostat begins. The regulation adds that an instrument with specialized uses in a specific medical specialty is classified in its own regulation in parts 868 through 892. That is why the types below sit under several different CFR sections. For the hemostat family specifically, see what a hemostat is; for one named example, see the Doyen clamp.
Types of surgical clamps: decision table
Each row below is a clamp type that FDA regulation names and defines. “FDA class” is the classification in the cited CFR section.
| Clamp type | What the regulation says it is | FDA class and section | Limits of the entry |
|---|---|---|---|
| General-use surgical clamp | “Clamp” is listed among nonpowered, hand-held or hand-manipulated instruments for various general surgical procedures; reusable or disposable. | Class I, exempt from 510(k) subject to limits in 21 CFR 878.9 (21 CFR 878.4800; product codes GDJ, HXD) | Covers general use only; specialty clamps are classified elsewhere. |
| Vascular clamp | “A surgical instrument used to occlude a blood vessel temporarily.” | Class II, performance standards (21 CFR 870.4450; product code DXC) | Defined by function (temporary occlusion), not by jaw shape or size. |
| Umbilical clamp | “An instrument used to compress the umbilical cord.” | Class II, special controls; umbilical clamps with or without a cutter are exempt from 510(k) subject to limits in 21 CFR 884.9 (21 CFR 884.4530; product codes HFW, NBZ) | See the umbilical cord clamp guide for hospital stocking basics. |
| Circumcision clamp | “An instrument used to compress the foreskin of the penis during circumcision of a male infant.” | Class II (21 CFR 884.4530; product code HFX) | Single-procedure instrument; no general-surgery use is stated. |
| Gastroenterology-urology clamps (line clamp, non-electrical clamp, locking device for intestinal clamp) | Named among manual gastroenterology-urology surgical instruments that “may be nonpowered, hand-held, or hand-manipulated”. | Class I (21 CFR 876.4730; product codes FFN, FKK, FFR) | The regulation lists the names; it does not define each type separately. |
Other clamp product codes in the FDA database
Product codes and FDA classes for further clamp types under specialty regulations.
| Product code and name | FDA class | Regulation |
|---|---|---|
| HGC, Clamp, Uterine | 1 | 21 CFR 884.4520 |
| HCE, Clamp, Carotid Artery | 2 | 21 CFR 882.5175 |
| HOB, Clamp, Muscle, Ophthalmic; HOD, Clamp, Eyelid, Ophthalmic | 1 | 21 CFR 886.4350 |
| EEF, Clamp, Rubber Dam | 1 | 21 CFR 872.6300 |
| FIG, Clamp, Tubing, Blood, Automatic | 2 | 21 CFR 876.5820 |
How FDA classification differs between clamps
Class I means general controls apply, and the general-use clamp in 21 CFR 878.4800 is exempt from premarket notification (510(k)) subject to limitations. Class II adds special controls or performance standards; the vascular clamp rule states “Class II (performance standards)”.
What to check on the label
- The device name and product code against the tables above, since the same physical shape can be sold under a general-use or a specialty name.
- Reusable or disposable. The general-use regulation covers both. The openFDA database also carries a separate product code, NMF, “Clamp, Vascular, Reprocessed”, Class II under 21 CFR 870.4450, so reprocessed vascular clamps are a distinct listed category.
- The manufacturer’s instructions for use for sterilization, handling and any limits on the specific model; this page does not replace them.
FAQ
Is a surgical clamp the same as a hemostat?
Not in the regulation’s wording. 21 CFR 878.4800 lists “clamp” and “hemostat” as separate items within the same general-use instrument group, both Class I. Catalogs often use the words loosely. See medical forceps types for the neighboring instrument family.
What FDA class is a surgical clamp?
It depends on the type. A general-use clamp is Class I (21 CFR 878.4800); vascular, umbilical and circumcision clamps are Class II (21 CFR 870.4450 and 884.4530), as checked on 2026-10-30.
Are surgical clamps reusable?
The general-use regulation covers devices that are “either reusable or disposable”. Whether a particular clamp is single-use is stated on its label and instructions for use.
Sources
- 21 CFR 878.4800, manual surgical instrument for general use, checked 2026-10-30.
- 21 CFR 870.4450, vascular clamp, checked 2026-10-30.
- 21 CFR 884.4530, obstetric-gynecologic specialized manual instruments (umbilical and circumcision clamps), checked 2026-10-30.
- 21 CFR 876.4730, manual gastroenterology-urology surgical instruments, checked 2026-10-30.
- openFDA device classification database, clamp product codes, checked 2026-10-30.
Related CASRAI pages: orthopedic surgical instruments.
