510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K990349Substantially Equivalent

Wallace Malleable Stylet-18Cm, Model 1816St, Wallace Malleable Stylet-23Cm, Model 1816Nst

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

K990349 is the FDA 510(k) clearance record for WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST, a class II device, cleared for CooperSurgical, Inc. on under FDA product code MQF (Catheter, Assisted Reproduction). FDA records list 103 510(k) clearances for CooperSurgical, Inc., from to . As of , FDA records show 6 recalls naming K990349.

Clearance record

Decision date
Received
(171 days to decision)
Product code
MQF Catheter, Assisted Reproduction
Regulation
21 CFR 884.6110
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
CooperSurgical, Inc. 15 Forest Pkwy., Shelton CT
510(k) summary
Summary
Third party review
No

Clearances, product code MQF

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