Cleared Traditional

K810807 - HOLLISEAL OSTOMY SKIN BARRIER

K810807 is an FDA 510(k) clearance for HOLLISEAL OSTOMY SKIN BARRIER, 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 14-day FDA review.

K810807 · Hollister, Inc. · Gastroenterology & Urology device
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Apr 1981
Decision
14d
Days
Class 1
Risk

K810807 is an FDA 510(k) clearance for the HOLLISEAL OSTOMY SKIN BARRIER. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Hollister, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 7, 1981 after a review of 14 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 - K810807

510(k) Number K810807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1981
Decision Date April 07, 1981
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
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 K810807.
DRAINING-WOUND MGMT. SYSTEM
K810812 · Johnson & Johnson Professionals, Inc. · Apr 1981
HOLLISTER SKIN BARRIER A
K810709 · Hollister, Inc. · Apr 1981
HOLLISTER SKIN BARRIER B
K810710 · Hollister, Inc. · Apr 1981
ADHESIVE PERISTOMAL COVERING W/WO CONN.
K803082 · Johnson & Johnson Professionals, Inc. · Dec 1980
CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON
K802677 · Johnson & Johnson Professionals, Inc. · Nov 1980
SUR-FIT SYSTEM STERILE O.R. SETS
K801703 · E. R. Squibb & Sons, Inc. · Sep 1980