Cleared Traditional

K926290 - BURN SHEET

K926290 is an FDA 510(k) clearance for BURN SHEET, manufactured by Gam Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FPY cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K926290 · Gam Industries, Inc. · General & Plastic Surgery device
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Apr 1993
Decision
127d
Days
Class 1
Risk

K926290 is an FDA 510(k) clearance for the BURN SHEET. Classified as Sheet, Burn (product code FPY), Class I - General Controls.

Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5180 - the FDA general and plastic surgery device framework. 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 Gam Industries, Inc. devices

FDA 510(k) Submission Details - K926290

510(k) Number K926290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date April 20, 1993
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

FPY Device Classification - Class 1, General Controls

Product Code FPY Sheet, Burn
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5180
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FPY Sheet, Burn

Devices cleared under the same product code (FPY) and FDA review panel - the closest regulatory comparables to K926290.
LYOSHEET SURGICAL SHEET FOR BURNS
K871740 · Acme United Corp. · Jun 1987
KENDALL CURITY BURN PAD
K853145 · The Kendal Co. · Aug 1985
ABSORB FURN SHEET
K820994 · American Convertors Div., American Pharmaseal · May 1982
TEMPORARY BURN SHEET WITH PERFORATED
K792432 · American Medical Disposable, Inc. · Dec 1979
TEMPORARY BURN SHEET WITH PERFORATED
K792433 · American Medical Disposable, Inc. · Dec 1979