Cleared Traditional

K813296 - CONVERTORS STERILE DISP. LAP SPONGE II

K813296 · American Convertors Div., American Pharmaseal · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1981
Decision
36d
Days
-
Risk

K813296 is an FDA 510(k) clearance for the CONVERTORS STERILE DISP. LAP SPONGE II. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by American Convertors Div., American Pharmaseal (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 36 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 American Convertors Div., American Pharmaseal devices

FDA 510(k) Submission Details - K813296

510(k) Number K813296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1981
Decision Date December 29, 1981
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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 K813296.
NU-GAUZE SPONGE
K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982
X-RAY GUAZE SPONGES
K820106 · Stan-Pak Ent. · Feb 1982
GUAZE SPONGES, PLAIN
K820107 · Stan-Pak Ent. · Feb 1982
SOFTCARE BARRIER WET DRESSING
K812736 · The Kendal Co. · Nov 1981
POST OP. SPONGES STERILE
K802860 · Abco Dealers, Inc. · Dec 1980
COMBINATION PADS STERILE SINGLES
K802861 · Abco Dealers, Inc. · Dec 1980