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This page describes products and general use; it is not medical advice.
A Gomco clamp is a circumcision clamp built around a bell and a base plate, and in the United States it is regulated as a Class II device under product code HFX. Purchasing and clinical-engineering staff, clinic managers and students use this page to identify the device class, read the regulatory record behind it, and know which documents to ask a supplier for.
What a Gomco clamp is
The Gomco clamp is a circumcision clamp. A 1998 article in American Family Physician (AFP) described it as one of the leading instruments used for non-ritual circumcision in the United States; that is a dated clinical statement, not a current market share figure. It is a different product from a umbilical cord clamp, even though both are filed in the same FDA regulation. For the wider family of instruments, see types of surgical clamps.
Who uses it: clinicians who perform newborn and infant circumcision, and the staff who stock, inspect and reprocess the instrument.
How it is built: bell, base plate and clamp
The AFP article names the working parts as a bell, a base plate with a hole in it, and the clamp itself, and it lists choosing the correct size of Gomco bell and clamp among the technique-related issues. The bell and clamp therefore need to be matched, which is the main reason a supplier’s listing should state exactly which bell sizes and which clamp frame are supplied together.
Gomco, Mogen and Plastibell in FDA records
Gomco, Mogen and Plastibell are commonly mentioned together. In the FDA 510(k) database all circumcision clamps sit under one product code, HFX (“Clamp, circumcision”). The table lists records returned by openFDA for that code; each row is a cleared 510(k) as the FDA names it, not a statement about how the devices differ in use.
| Device name as listed by FDA | Applicant | 510(k) number | Decision date |
|---|---|---|---|
| Gomco circumcision clamp | Zinnanti Surgical Instruments, Inc. | K894201 | 1989-08-11 |
| Gomco circumcision clamp | Thomasville Medical Assoc. | K926535 | 1994-02-25 |
| Gomco circumcision clamp, Mogen clamp, Plastibell circumcision device (one submission) | Clinical Innovations, LLC | K061539 | 2007-09-20 |
| Medicon Mogen clamp | Medicon EG | K100916 | 2010-12-06 |
| Konig Mogen clamp | Medline Industries, Inc. | K212911 | 2022-11-18 |
| Konig Bell circumcision clamp | Medline Industries, LP | K251687 | 2026-02-25 |
Source: openFDA 510(k) endpoint (https://api.fda.gov/device/510k.json?search=product_code:HFX), checked 2026-11-03. A brand name on a supplier page is not itself proof of clearance; the 510(k) number is what to look up.
Regulation and labeling: HFX and 21 CFR 884.4530
- Product code and name: HFX, “Clamp, circumcision” (FDA Product Classification database, checked 2026-11-03).
- Regulation: 21 CFR 884.4530, obstetric-gynecologic specialized manual instrument (Cornell LII copy of the CFR, checked 2026-11-03).
- Class and pathway: Class II; submission type 510(k); medical specialty Obstetrics/Gynecology. The regulation exempts certain devices from premarket notification, such as some umbilical clamps, but circumcision clamps are not among the exemptions it names.
- Good manufacturing practice exemption: the FDA record lists “GMP exempt: No”.
The manufacturer or importer should also appear as a FDA-registered establishment, and device problems are handled through medical device reporting (MDR). The agency itself is covered in FDA, Food and Drug Administration.
What one device record shows: a worked example
AccessGUDID, the National Library of Medicine’s public Unique Device Identification database, holds a record for a “Gomco Type Circumcision Clamp” (Fine Surgical Instruments, model 28-856, described as disposable, chrome plated, infant, 1.45 cm). In that record, checked 2026-11-03: the device is not packaged sterile and labeling says it requires sterilization before use by moist heat (steam); it is marked single use; its MR status is “MR Unsafe”; and the product code is HFX. This is one listed example, not a rule for every Gomco clamp: other makers may label sterility, reuse and sizes differently, which is exactly why each product’s own record and instructions for use need checking.
What to ask a supplier for
Every item below is something the sources above show can differ between products or can be looked up.
- 510(k) number and product code: confirm HFX and look up the number in the FDA database.
- Unique Device Identifier: search the device identifier in AccessGUDID to compare the record with the listing.
- Sterile or non-sterile supply: the example record is supplied non-sterile and needs sterilization before use.
- Single use or reusable: the example record is labeled single use; do not assume this for another product.
- Bell and clamp matching: AFP lists bell and clamp size matching as a point to get right, so ask which bell sizes belong to which clamp.
- Instructions for use: reprocessing, inspection and storage instructions come from the manufacturer’s labeling.
- MR labeling: request it if the instrument could be present in an MR environment; the example record is MR Unsafe.
Safe use and handling basics
Handle, inspect, sterilize and discard the instrument only as the manufacturer’s instructions for use state. Where the labeling says single use, the device is not reprocessed. Damaged or mismatched parts are not used. Product problems that may have caused or contributed to injury can be reported under the FDA’s device reporting system. Clinical technique belongs in clinician training and professional guidance, not in a procurement page.
Common mistakes
- Treating a circumcision clamp and an umbilical cord clamp as the same product because they share a regulation number.
- Treating “Gomco-type” in a listing as proof of FDA clearance without checking the 510(k) number.
- Assuming one record’s sterile, reuse or size labeling applies to every Gomco-style clamp.
- Mixing bells and clamp frames from different sets.
FAQ
Is a Gomco clamp the same as a Mogen clamp or Plastibell?
They are separate devices with their own FDA names, but FDA files circumcision clamps under the single product code HFX. One 2007 submission (K061539) covered Gomco, Mogen and Plastibell devices together.
What is in a circumcision kit or tray?
FDA lists circumcision trays and kits as separate 510(k) records under HFX (for example a Baxter disposable circumcision tray, K884290, and a Medline circumcision tray, K970282), and contents differ by supplier. Check the manufacturer’s packing list and labeling for the kit you are considering.
What FDA class is a Gomco clamp?
Class II under 21 CFR 884.4530, product code HFX, with a 510(k) submission type.
Does a Gomco clamp come sterile?
It depends on the product. The AccessGUDID example above is not packaged sterile and requires steam sterilization before use per its labeling.
Sources
All sources below were checked on 2026-11-03.
- FDA Product Classification, product code HFX: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=HFX
- 21 CFR 884.4530: https://www.law.cornell.edu/cfr/text/21/884.4530
- openFDA device 510(k) API, product code HFX: https://api.fda.gov/device/510k.json?search=product_code:HFX
- AccessGUDID record, device identifier 00869401000220: https://accessgudid.nlm.nih.gov/devices/00869401000220
- Peleg D, Steiner A. The Gomco Circumcision: Common Problems and Solutions. American Family Physician 1998;58(4):891-898: https://www.aafp.org/pubs/afp/issues/1998/0915/p891.html
