Cleared Traditional

K891460 - NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE

K891460 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Apr 1989
Decision
33d
Days
-
Risk

K891460 is an FDA 510(k) clearance for the NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on April 17, 1989 after a review of 33 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 - K891460

510(k) Number K891460 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 15, 1989
Decision Date April 17, 1989
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
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 K891460.
SERENE WRAP
K895865 · Byron Medical · Dec 1989
LAP SPONGE
K896801 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
K896490 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1989
STERILE LAPAROTOMY SPONGES
K890770 · Cypress Medical Products, Ltd. · Mar 1989
NON-STERILE, BULK GAUZE SPONGES
K890727 · Cypress Medical Products, Ltd. · Mar 1989
ABSORBENT GAUZE ROLL
K885143 · Smith & Nephew, Inc. · Feb 1989