510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000628Substantially Equivalent

Wallace Oocyte Retrieval Set-16G, Model Meons1633; Wallace Oocyte Retrieval Set-17G, Model Meons1733

Abbott Medical, Hythe, Kent, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000628 is the FDA 510(k) clearance record for WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733, a class II device, cleared for Sims Portex , Ltd. on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show one recall naming K000628.

Clearance record

Decision date
Received
(18 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sims Portex , Ltd. Hythe, Hythe, Kent, GB
510(k) summary
Summary
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