Cleared Traditional

K872624 - INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING

K872624 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Jul 1987
Decision
23d
Days
-
Risk

K872624 is an FDA 510(k) clearance for the INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on July 29, 1987 after a review of 23 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 - K872624

510(k) Number K872624 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 06, 1987
Decision Date July 29, 1987
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 K872624.
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · Coloplast A/S · Nov 1987
D.R.P. THREE STEP WOUND DRESSING
K871327 · Bioderm, Inc. · Nov 1987
FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID
K871675 · Ferris Mfg. Corp. · Aug 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913 · Beiersdorf, Inc. · Jul 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770 · American Pharmaseal Div. Ahsc · Jun 1987
ELASTO-GEL OCCLUSIVE DRESSING
K872165 · Southwest Technologies, Inc. · Jun 1987
K872624 · INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
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