510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141365Substantially Equivalent

Otrieva Tapered Ovum Aspiration Needle Single Lumen

William A. Cook Australia Pty, Ltd., Eight Mile Plains, Queensland, AU / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141365 is the FDA 510(k) clearance record for OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN, a class II device, cleared for William A. Cook Australia Pty. , Ltd. on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list 14 510(k) clearances for William A. Cook Australia Pty. , Ltd., from to . As of , FDA records show no recalls naming K141365.

Clearance record

Decision date
Received
(76 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
William A. Cook Australia Pty. , Ltd. 95 Brandl St., Eight Mile Plains, Queensland, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQE

Trailing 12 months
1 clearance under product code MQE in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260