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Bozeman Uterine Forceps, Straight, 10+410 0R 420

by The Huxley Instrument Corp.

510(k) K852721

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852721 Date6 Sep 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HCZ
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Bozeman Uterine Forceps, Straight, 10+410 0R 420 is a surgical instrument classified as a gynecological forceps. It is designed for obstetric and gynecological procedures, providing controlled manipulation of uterine tissue or foreign bodies during surgical interventions.

This reusable device is intended for use in clinical settings and has received FDA 510(k) clearance under the classification of Surgical, Gynecological Forceps. The forceps are manufactured by The Huxley Instrument Corp. and fall under regulation number 884.4530, adhering to standard surgical instrument guidelines. No specific sterility or MRI safety information is provided in the data.

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