510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970443Substantially Equivalent

Hollister Retracted Penis Pouch

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

K970443 is the FDA 510(k) clearance record for HOLLISTER RETRACTED PENIS POUCH, a class I device, cleared for Hollister, Inc. on under FDA product code EXI (Device, Paste-On For Incontinence, Sterile). FDA records list 85 510(k) clearances for Hollister, Inc., from to . As of , FDA records show no recalls naming K970443.

Clearance record

Decision date
Received
(20 days to decision)
Product code
EXI Device, Paste-On For Incontinence, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Hollister, Inc. 2000 Hollister Dr., Libertyville IL
510(k) summary
Summary
Third party review
No

Clearances, product code EXI

Trailing 12 months

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

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