Cleared Traditional

FALKON STRETCH (K854432) - FDA 510(k) Clearance

K854432 · G.B.F. Industries, Inc. · General & Plastic Surgery device
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Nov 1985
Decision
17d
Days
-
Risk

K854432 is an FDA 510(k) clearance for the FALKON STRETCH. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by G.B.F. Industries, Inc. (New York, US). The FDA issued a Cleared decision on November 22, 1985 after a review of 17 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 G.B.F. Industries, Inc. devices

Submission Details

510(k) Number K854432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1985
Decision Date November 22, 1985
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -