Cleared Traditional

K961773 - PROTEC STERILE GAUZE SPONGE (FDA 510(k) Clearance)

K961773 · Derivadas Degasa S.A. DE C.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
82d
Days
-
Risk

K961773 is an FDA 510(k) clearance for the PROTEC STERILE GAUZE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Derivadas Degasa S.A. DE C.V. (Tarpon Springs, US). The FDA issued a Cleared decision on July 29, 1996 after a review of 82 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 Derivadas Degasa S.A. DE C.V. devices

Submission Details

510(k) Number K961773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1996
Decision Date July 29, 1996
Days to Decision 82 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
32d faster than avg
Panel avg: 114d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -