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ONE/CIRC Circumcision Clamp

by Bionix Development Corp.

510(k) K900370

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900370 Date16 Apr 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ONE/CIRC Circumcision Clamp is a surgical device classified as a clamp for neonatal or adult circumcision procedures. It is designed to hold the foreskin in place, providing a controlled guide for excision while minimizing bleeding and ensuring a uniform resection. This device is intended for use during circumcision to improve precision and reduce procedural variability.

The ONE/CIRC Circumcision Clamp is supplied as a single-use, non-sterile device (sterilized prior to use) and is regulated under FDA 510(k) clearance (K900370) with a product code of HFX. It falls under 21 CFR 884.4530, classified as a Class II device. Storage and handling must comply with standard surgical instrument protocols, and it is intended for use in obstetrics/gynecology settings.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ONE/CIRC Circumcision Clamp used for?

    The ONE/CIRC Circumcision Clamp is designed specifically for neonatal or adult circumcision procedures. It holds the foreskin securely in place, guiding the excision process with precision. This reduces variability in the procedure and minimizes bleeding, ensuring a more uniform resection outcome.

  • Is the ONE/CIRC Circumcision Clamp single-use or reusable?

    The ONE/CIRC Circumcision Clamp is supplied as a single-use device. It is non-sterile initially but must be sterilized prior to use. This ensures patient safety and compliance with standard surgical protocols.

  • How should the ONE/CIRC Circumcision Clamp be stored?

    The ONE/CIRC Circumcision Clamp must be stored and handled according to standard surgical instrument protocols. Since it is single-use and non-sterile initially, it should be kept in a clean, dry environment until sterilization is performed prior to use.

  • In which medical specialty is the ONE/CIRC Circumcision Clamp primarily used?

    The ONE/CIRC Circumcision Clamp is primarily intended for use in obstetrics and gynecology settings. It is classified under the FDA’s product code HFX and falls under the regulatory category 21 CFR 884.4530, which aligns with its specialized use in circumcision procedures.

  • What regulatory pathway does the ONE/CIRC Circumcision Clamp follow?

    The ONE/CIRC Circumcision Clamp is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K900370. It is classified as a Class II device, indicating it has undergone review by the Obstetrics/Gynecology Advisory Committee to ensure its safety and effectiveness for the intended use.