Cleared Traditional

K991757 - NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE

K991757 · Furlong Industries · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
80d
Days
-
Risk

K991757 is an FDA 510(k) clearance for the NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Furlong Industries (Grayslake, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 80 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.

FDA 510(k) Submission Details - K991757

510(k) Number K991757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1999
Decision Date August 12, 1999
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
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 270
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K991757.
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
K991215 · Symtex Healthcare Corp. · Jun 1999
VITOP DRESSING
K990974 · Wonder & Bioenergy Hi-Tech America, Inc. · Jun 1999
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
K990584 · Broadline Medical Industries · Apr 1999
CROSSTEX NON-WOVEN SPONGES
K984187 · Crosstex Intl. · Feb 1999
GAUZE, SPONGES, CAT # 11-003
K983016 · Vitalcare Group, Inc. · Feb 1999
DYNAREX TRACHEOSTOMY SPONGE
K983348 · Dynarex Corp. · Dec 1998
K991757 · NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
Download PDF FDA Summary Furlong Industries