Cleared Traditional

K961775 - PROFORE FOUR-LAYER BANDAGE SYSTEM KIT

K961775 · Smith & Nephew United, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
69d
Days
-
Risk

K961775 is an FDA 510(k) clearance for the PROFORE FOUR-LAYER BANDAGE SYSTEM KIT. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on July 16, 1996 after a review of 69 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 Smith & Nephew United, Inc. devices

FDA 510(k) Submission Details - K961775

510(k) Number K961775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1996
Decision Date July 16, 1996
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K961775.
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
K963134 · Igenics, Inc. · Sep 1996
PRO-FECT STERILE GAUZE SPONGES
K962227 · Network Trading Corp. Dba Grand Intl. · Aug 1996
PROTEC STERILE GAUZE SPONGE
K961773 · Derivadas Degasa S.A. DE C.V. · Jul 1996
STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)
K962234 · Howard Medical Co. · Jun 1996
CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
K961061 · Codi International BV · Jun 1996
EMERALD STERILE GAUZE SPONGE
K961581 · Emerald Medical, Inc. · May 1996