Cleared Traditional

K770446 - SPONGES

K770446 · Walpak Co. · General & Plastic Surgery device
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Jun 1977
Decision
100d
Days
-
Risk

K770446 is an FDA 510(k) clearance for the SPONGES, LAPAROTOMY. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Walpak Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1977 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Walpak Co. devices

Submission Details

510(k) Number K770446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1977
Decision Date June 15, 1977
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 44
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K770446.
VAGINAL PACKING
K792431 · American Medical Disposable, Inc. · Dec 1979
BURN PAD, DRY, STERILE
K781985 · Chesebrough-Pond'S U.S.A. Co. · Dec 1978
LAPOROTOMY SPONGE
K780806 · Abco Dealers, Inc. · Jun 1978
INTERSORB LAPAROTOMY SPONGE
K761037 · Chesebrough-Pond'S U.S.A. Co. · Dec 1976
SPONGE, LAPAROTOMY GAUZE
K760113 · Parke-Davis Co. · Jul 1976