Cleared Traditional

K760113 - SPONGE, LAPAROTOMY GAUZE (FDA 510(k) Clearance)

K760113 · Parke-Davis Co. · General & Plastic Surgery device
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Jul 1976
Decision
21d
Days
-
Risk

K760113 is an FDA 510(k) clearance for the SPONGE, LAPAROTOMY GAUZE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Parke-Davis Co. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1976 after a review of 21 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 Parke-Davis Co. devices

Submission Details

510(k) Number K760113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1976
Decision Date July 15, 1976
Days to Decision 21 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
93d faster than avg
Panel avg: 114d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -