Cleared Traditional

K791534 - HOLLISTER UROSTOMY POUCH

K791534 is an FDA 510(k) clearance for HOLLISTER UROSTOMY POUCH, manufactured by Hollister, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K791534 · Hollister, Inc. · Gastroenterology & Urology device
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Oct 1979
Decision
60d
Days
Class 1
Risk

K791534 is an FDA 510(k) clearance for the HOLLISTER UROSTOMY POUCH. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Hollister, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 9, 1979 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hollister, Inc. devices

FDA 510(k) Submission Details - K791534

510(k) Number K791534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date October 09, 1979
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

EXB Device Classification - Class 1, General Controls

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXB Collector, Ostomy

All 68
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K791534.
HOLLISTER KARAYA PASTE
K791525 · Hollister, Inc. · Oct 1979
HOLLISTER STOMA POUCH SKIN BARRIER
K791526 · Hollister, Inc. · Oct 1979
HOLLISTER STOMA POUCH WITH MICRO ADHES
K791535 · Hollister, Inc. · Oct 1979
COLOPLAST CARBON GAS FILTER
K791581 · C.R. Bard, Inc. · Oct 1979
OSTOMY APPLIANCE W/DEODORIZING FILTER
K781373 · Hollister, Inc. · Sep 1978
OSTOMY APPLIANCE BELT
K781088 · E. R. Squibb & Sons, Inc. · Aug 1978