Cleared Traditional

K885143 - ABSORBENT GAUZE ROLL

K885143 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Feb 1989
Decision
57d
Days
-
Risk

K885143 is an FDA 510(k) clearance for the ABSORBENT GAUZE ROLL. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Smith & Nephew, Inc. (Miami, US). The FDA issued a Cleared decision on February 10, 1989 after a review of 57 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, Inc. devices

FDA 510(k) Submission Details - K885143

510(k) Number K885143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1988
Decision Date February 10, 1989
Days to Decision 57 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
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 K885143.
NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE
K891460 · Smith & Nephew United, Inc. · Apr 1989
STERILE LAPAROTOMY SPONGES
K890770 · Cypress Medical Products, Ltd. · Mar 1989
NON-STERILE, BULK GAUZE SPONGES
K890727 · Cypress Medical Products, Ltd. · Mar 1989
GAUZE SWABS, NON-STERILE
K885142 · Smith & Nephew, Inc. · Jan 1989
GAUZE SPONGE
K882527 · Ormed Mfg., Inc. · Jul 1988
CYLINDRICAL SPONGE
K882528 · Ormed Mfg., Inc. · Jul 1988