510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801504Substantially Equivalent

Hollister Drainage Pouch

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

K801504 is the FDA 510(k) clearance record for HOLLISTER DRAINAGE POUCH, a class I device, cleared for Hollister, Inc. on under FDA product code FON (Bag, Drainage, With Adhesive, Ostomy). FDA records list 85 510(k) clearances for Hollister, Inc., from to . As of , FDA records show no recalls naming K801504.

Clearance record

Decision date
Received
(46 days to decision)
Product code
FON Bag, Drainage, With Adhesive, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Hollister, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FON

Trailing 12 months

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

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