Cleared Traditional

K780806 - LAPOROTOMY SPONGE

K780806 · Abco Dealers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1978
Decision
43d
Days
-
Risk

K780806 is an FDA 510(k) clearance for the LAPOROTOMY SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978 after a review of 43 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 Abco Dealers, Inc. devices

FDA 510(k) Submission Details - K780806

510(k) Number K780806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1978
Decision Date June 22, 1978
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
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 K780806.
VAGINAL PACKING
K792431 · American Medical Disposable, Inc. · Dec 1979
BURN PAD, DRY, STERILE
K781985 · Chesebrough-Pond'S U.S.A. Co. · Dec 1978
SPECIALTY SPONGES
K781420 · Ipco Corp. · Oct 1978
INTERSORB LAPAROTOMY SPONGE
K761037 · Chesebrough-Pond'S U.S.A. Co. · Dec 1976
SPONGE, LAPAROTOMY GAUZE
K760113 · Parke-Davis Co. · Jul 1976