Cleared Traditional

K780294 - G WRAP

K780294 is an FDA 510(k) clearance for G WRAP, manufactured by Cel-Fibe. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K780294 · Cel-Fibe · General Hospital
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Mar 1978
Decision
35d
Days
Class 2
Risk

K780294 is an FDA 510(k) clearance for the G WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Cel-Fibe (Mchenry, US). The FDA issued a Cleared decision on March 28, 1978 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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: 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 Cel-Fibe devices

FDA 510(k) Submission Details - K780294

510(k) Number K780294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1978
Decision Date March 28, 1978
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 241
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K780294.
VAL-U-WRAP CSR WRAP
K801569 · American Convertors Div., American Pharmaseal · Jul 1980
AMPCO SKIN SCRUB TRAYS
K801332 · Associated Medical Products Co. · Jun 1980
HYPERALIMENTATION DRESSING TRAY
K792369 · Pharmaseal Div., Baxter Healthcare Corp. · Dec 1979
AUTOCLAVE POUCHES&ROLLS/STEAM&GAS
K780034 · E.M. Adams · Feb 1978
SUOGIPEEL PACKAGING SYSTEM
K771846 · Surgicot, Inc. · Oct 1977
POUCHES, PEEL OPEN, BREATHABLE
K771032 · Surgicot, Inc. · Jul 1977