510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K862934Substantially Equivalent

Hollister Female Urinary Collection Pouch

Hollister, Inc., Libertyville IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862934 is the FDA 510(k) clearance record for HOLLISTER FEMALE URINARY COLLECTION POUCH, a class II device, cleared for Hollister, Inc. on under FDA product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter). FDA records list 85 510(k) clearances for Hollister, Inc., from to . As of , FDA records show no recalls naming K862934.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Hollister, Inc. 2000 Hollister Dr., Libertyville IL
Third party review
No

Clearances, product code KNX

Trailing 12 months

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

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