510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964848Substantially Equivalent

Wallace Artificial Insemination Catheter - 8Cm/18cm

Marlow Surgical Technologies, Inc., Willoughby OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964848 is the FDA 510(k) clearance record for WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM, a class II device, cleared for Marlow Surgical Technologies, Inc. on under FDA product code MFD (Cannula, Intrauterine Insemination). FDA records list 2 510(k) clearances for Marlow Surgical Technologies, Inc., from to . As of , FDA records show one recall naming K964848.

Clearance record

Decision date
Received
(44 days to decision)
Product code
MFD Cannula, Intrauterine Insemination
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Marlow Surgical Technologies, Inc. 1810 Joseph Lloyd Pkwy., Willoughby OH
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