Cleared Traditional

K896801 - LAP SPONGE

K896801 · Westmark, Sterile Packing Systems, Inc. (Sps) · General & Plastic Surgery device
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Dec 1989
Decision
26d
Days
-
Risk

K896801 is an FDA 510(k) clearance for the LAP SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on December 27, 1989 after a review of 26 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 - K896801

510(k) Number K896801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date December 27, 1989
Days to Decision 26 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
89d faster than avg
Panel avg: 115d · This submission: 26d
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 194
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K896801.
GAUZE SPONGES, INTERNAL AND EXTERNAL
K905136 · American Healthcare Corp. · Mar 1991
MEDI-SURE, MEDI-SORB
K897180 · Gulf Coast Medical, Inc. · Aug 1990
SERENE WRAP
K895865 · Byron Medical · Dec 1989
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
K896490 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1989
GAUZE SPONGE
K895086 · Keilei Intl., Inc. · Oct 1989
COTOLIN DRAIN SPONGE AND DRESSING SPONGE
K894505 · James River Corp. · Sep 1989
K896801 · LAP SPONGE
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