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Ovum Forceps

by Thomasville Medical Assoc.

510(k) K926528

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK926528 Date24 Feb 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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, 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 Ovum Forceps is a surgical instrument classified under gynecological forceps, designed for obstetric and gynecological procedures. It is specifically used to grasp, manipulate, or extract the ovum (egg) during reproductive interventions, such as in vitro fertilization (IVF) or other assisted reproductive technologies.

This device is supplied as a reusable surgical instrument and is regulated under FDA 510(k) clearance (K926528) with product code HCZ. It falls under Class II medical devices, adhering to obstetrics/gynecology standards, and is intended for use in clinical settings where sterile conditions are maintained. No additional regulatory markings or MRI safety classifications are specified.

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