510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K941528Substantially Equivalent

Pearl Packing Forceps

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941528 is the FDA 510(k) clearance record for PEARL PACKING FORCEPS, a class II device, cleared for Cook Urological, Inc. on under FDA product code HCZ (Forceps, Surgical, Gynecological). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K941528.

Clearance record

Decision date
Received
(43 days to decision)
Product code
HCZ Forceps, Surgical, Gynecological
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Summary
Third party review
No

Clearances, product code HCZ

Trailing 12 months

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

FDA records show no clearances under product code HCZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCZ, 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