Cleared Traditional

K872926 - DERMATOLOGICAL PATCH

K872926 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
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Feb 1988
Decision
210d
Days
-
Risk

K872926 is an FDA 510(k) clearance for the DERMATOLOGICAL PATCH. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on February 22, 1988 after a review of 210 days - an extended review cycle.

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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K872926 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 27, 1987
Decision Date February 22, 1988
Days to Decision 210 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
95d slower than avg
Panel avg: 115d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 222
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K872926.
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
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · Coloplast A/S · Nov 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913 · Beiersdorf, Inc. · Jul 1987