Cleared Traditional

ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 (K974891) - FDA 510(k) Clearance

K974891 · Acutek Adhesive Specialties, Inc. · General & Plastic Surgery device
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Oct 1998
Decision
295d
Days
-
Risk

K974891 is an FDA 510(k) clearance for the ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Acutek Adhesive Specialties, Inc. (Inglewood, US). The FDA issued a Cleared decision on October 21, 1998 after a review of 295 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 Acutek Adhesive Specialties, Inc. devices

Submission Details

510(k) Number K974891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1997
Decision Date October 21, 1998
Days to Decision 295 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 115d · This submission: 295d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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