Cleared Traditional

K770889 - BURN DRESSING KIT

K770889 · The Owenby Co. · General & Plastic Surgery device
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Jul 1977
Decision
56d
Days
-
Risk

K770889 is an FDA 510(k) clearance for the BURN DRESSING KIT. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by The Owenby Co. (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977 after a review of 56 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 The Owenby Co. devices

Submission Details

510(k) Number K770889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1977
Decision Date July 11, 1977
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 K770889.
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