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Biopsy Medium, Model Ref 1062

by Medicult A/S

510(k) K060983

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 NumberK060983 Date28 Jul 2006ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1044-2023 FDA Class II initiated 15 Dec 2022

    The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.

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  • Withdrawn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
MQL
Device Class
Class II
Regulation
21 CFR Part 884.6180
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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