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Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061539

by Clinical Innovations, LLC

Identifiers

510(k) Number
K061539 FDA 510(k)
FDA Product Code
HFX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.4530 FDA 510(k)
Regulation Number
884.4530 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a circumcision instrument used to perform neonatal male circumcision. It includes three distinct mechanisms: the Gomco clamp, the Mogen clamp, and the Plastibell device, each designed to grasp, crush, and excise the penile foreskin in full-term newborn infants up to 10 days old.

The Gomco and Mogen clamps are reusable stainless steel instruments, while the Plastibell is a single-use device. All variants are classified under 21 CFR 884.4530 with product code HFX and are regulated under FDA 510(k) clearance (K061539). They are intended for use in obstetrics/gynecology settings and must be handled according to sterile procedures for neonatal care.

Frequently asked questions

What are the key differences between the reusable and single-use options in this circumcision device set?

The set includes two reusable stainless steel instruments—the Gomco clamp and the Mogen clamp—and one single-use device, the Plastibell. The reusable clamps are designed for repeated use in sterile procedures, while the Plastibell is intended for one-time use per patient, reducing cross-contamination risks. All three are meant for neonatal male circumcision in full-term infants up to 10 days old.

How should I store these devices to maintain their integrity and sterility?

The reusable Gomco and Mogen clamps should be stored in a clean, dry environment when not in use, following standard surgical instrument care protocols. The Plastibell, being single-use, should be stored in its original packaging until ready for use, ensuring it remains sterile and protected from contamination. Always adhere to obstetrics/gynecology sterile procedure guidelines.

Are these devices approved for use in all neonatal circumcision procedures, or are there specific patient age or condition restrictions?

These devices are specifically designed for full-term newborn infants up to 10 days old. They are not intended for premature infants or patients outside this age range. The Gomco, Mogen, and Plastibell clamps are all regulated under FDA 510(k) clearance for obstetrics/gynecology use, so their use should align with standard neonatal care protocols.

What regulatory pathway was followed for these devices, and how does that affect their use in clinical settings?

These devices were cleared through the FDA’s 510(k) process, specifically under the Traditional clearance type, with a decision code of SESE (Substantially Equivalent). This means they were determined to be comparable to a legally marketed predicate device and are regulated under 21 CFR 884.4530. Clinically, this clearance confirms their safety and effectiveness for neonatal male circumcision in obstetrics/gynecology settings, provided sterile procedures are followed.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device ..., Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device ..., Circumcision Instruments: Gomco Vs Plastibell Vs Surgical - Fizza Surgical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Clinical Innovations, LLC

Sources (1)

  • FDA 510(k) K061539 24 fields · synced Sep 18, 2026