Cleared Traditional

INTRASITE HYDROCOLLOID WOUND DRESSING (K911660) - FDA 510(k) Clearance

K911660 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Jun 1991
Decision
66d
Days
-
Risk

K911660 is an FDA 510(k) clearance for the INTRASITE HYDROCOLLOID WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on June 17, 1991 after a review of 66 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.

View all Smith & Nephew United, Inc. devices

Submission Details

510(k) Number K911660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1991
Decision Date June 17, 1991
Days to Decision 66 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -