Cleared Traditional

K881039 - HYDROCOLLOID DRESSING FOR PSORIASIS

K881039 · Hollister, Inc. · General & Plastic Surgery device
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Jun 1988
Decision
103d
Days
-
Risk

K881039 is an FDA 510(k) clearance for the HYDROCOLLOID DRESSING FOR PSORIASIS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on June 22, 1988 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hollister, Inc. devices

FDA 510(k) Submission Details - K881039

510(k) Number K881039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1988
Decision Date June 22, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 227
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K881039.
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · Baxter Healthcare Corp · Dec 1988
COMPEED ATHLETIC DRESSING
K883588 · Coloplast A/S · Sep 1988
DUODERM(R) HYDROACTIVE(R) PASTE
K881302 · Convatec, A Division of E.R. Squibb & Sons · Apr 1988
TEGASORB ULCER DRESSING #90-XXX
K872298 · 3M Company · Apr 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048 · Smith & Nephew, Inc. · Mar 1988