Cleared Traditional

BIO-DRESSING, STERILE ISLAND DRESSING (K961098) - FDA 510(k) Clearance

K961098 · K. W. Griffen Co. · General & Plastic Surgery device
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May 1996
Decision
45d
Days
-
Risk

K961098 is an FDA 510(k) clearance for the BIO-DRESSING, STERILE ISLAND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by K. W. Griffen Co. (Norwalk, US). The FDA issued a Cleared decision on May 3, 1996 after a review of 45 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 K. W. Griffen Co. devices

Submission Details

510(k) Number K961098 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 19, 1996
Decision Date May 03, 1996
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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