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Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158

by Apple Medical Corp.

510(k) K061651

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061651 Date20 Oct 2006ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1612-2022 FDA Class II initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

    • Terminated Z-1879-2018 FDA Class II initiated 12 Mar 2018

    Products have been packaged with an incorrect product size.

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  • Withdrawn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
HGI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 884.4120
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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