510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984306Substantially Equivalent

`The Inseminator' (Proposed)

CooperSurgical, Inc., Orange CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984306 is the FDA 510(k) clearance record for `THE INSEMINATOR' (PROPOSED), a class II device, cleared for Wallach Surgical Devices, Inc. on under FDA product code MFD (Cannula, Intrauterine Insemination). FDA records list 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show no recalls naming K984306.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MFD Cannula, Intrauterine Insemination
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Wallach Surgical Devices, Inc. 235 Edison Rd., Orange CT
510(k) summary
Summary
Third party review
No

Clearances, product code MFD

Trailing 12 months

FDA records hold no clearances under product code MFD in the trailing twelve months.

FDA records show no clearances under product code MFD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260