Cleared Traditional

COLLATEK SHEET (K012995) - FDA 510(k) Clearance

K012995 · Biocore Medical Technologies, Inc. · General & Plastic Surgery device
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Oct 2001
Decision
49d
Days
-
Risk

K012995 is an FDA 510(k) clearance for the COLLATEK SHEET. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Biocore Medical Technologies, Inc. (Silver Spring, US). The FDA issued a Cleared decision on October 25, 2001 after a review of 49 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 Biocore Medical Technologies, Inc. devices

Submission Details

510(k) Number K012995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date October 25, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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