Cleared Traditional

K892232 - ACTIDERM*-OPAQUE

K892232 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
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May 1989
Decision
31d
Days
-
Risk

K892232 is an FDA 510(k) clearance for the ACTIDERM*-OPAQUE. 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 May 5, 1989 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K892232

510(k) Number K892232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1989
Decision Date May 05, 1989
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
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 709
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K892232.
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K892360 · Pfizer, Inc. · Jun 1989
VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS
K891133 · Elwyn, Inc. · May 1989
WEDGE PRESSURE DRESSING
K891189 · Durden Enterprises, Inc. · May 1989
NU-DERM HYDROCOLLOID DRESSING
K890545 · Johnson & Johnson Patient Care, Inc. · Mar 1989
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K885321 · Pfizer Pharmaceuticals · Mar 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989
K892232 · ACTIDERM*-OPAQUE
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