Cleared Traditional

K896801 - LAP SPONGE (FDA 510(k) Clearance)

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.

View all Westmark, Sterile Packing Systems, Inc. (Sps) devices

Submission Details

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
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 114d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -