BIOPSY MEDIUM, MODEL REF 1062— 510(k) K060983

Substantially Equivalent

Medicult A/S

FDA 510(k) clearance K060983 for BIOPSY MEDIUM, MODEL REF 1062, Substantially Equivalent on 2006-07-28. Applicant: Medicult A/S. Device class: 2.

Clearance details

Applicant: Medicult A/S
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2006-04-10
Decision date: 2006-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQL

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K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more2025-08-27

More clearances from Medicult A/S

K080172 — BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 12162008-12-18
K081639 — ICSI CUMULASE2008-09-19
K080473 — EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED2008-09-03
K061309 — EMBRYOASSIST2007-02-08
K061145 — SPERMSLOW2006-10-02

Recalls naming K060983

K-number listed on FDA's recall record

Z-1044-2023 — BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)Class II·Ongoing·CooperSurgical, Inc.·20221215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060983.

Data sourced from openFDA. This site is unofficial and independent of the FDA.