Cleared Traditional

K870993 - 2, 3 AND 4 BANDAGE COMPRESS

K870993 · Advantage Credit Services, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
20d
Days
-
Risk

K870993 is an FDA 510(k) clearance for the 2, 3 AND 4 BANDAGE COMPRESS. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Advantage Credit Services, Inc. (Kansas City, US). The FDA issued a Cleared decision on March 31, 1987 after a review of 20 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 Advantage Credit Services, Inc. devices

FDA 510(k) Submission Details - K870993

510(k) Number K870993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1987
Decision Date March 31, 1987
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 157
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K870993.
FRASTEC DRY BURN DRESSING
K871916 · Fraass Survival Systems, Inc. · Jun 1987
FRASTEC DRY GAUZE BANDAGE
K871917 · Fraass Survival Systems, Inc. · Jun 1987
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52
K871438 · Fraass Survival Systems, Inc. · May 1987
SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES
K864175 · Fraass Survival Systems, Inc. · Nov 1986
GAUZE, ABSORBENT, STERILE, COMPRESSED
K863932 · Fraass Survival Systems, Inc. · Oct 1986
BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZES
K863713 · Fraass Survival Systems, Inc. · Oct 1986