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
K914934Unknown

Hand Pack

Westmark Hospital Supplies, Grand Rapids MI / Traditional, Unknown
FDA source (opens on fda.gov)

K914934 is the FDA 510(k) clearance record for HAND PACK, a class II device, cleared for Westmark Hospital Supplies on under FDA product code KDO (Rongeur, Cystoscopic, Hot). FDA records list 7 510(k) clearances for Westmark Hospital Supplies, from to . As of , FDA records show no recalls naming K914934.

Clearance record

Decision date
Received
(444 days to decision)
Product code
KDO Rongeur, Cystoscopic, Hot
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Westmark Hospital Supplies 1253 Ramona SE, Grand Rapids MI
510(k) summary
Statement
Third party review
No

Clearances, product code KDO

Trailing 12 months

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

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