Cleared Traditional

K820302 - SURGIPEEL SELF-SEAL PACKAGING SYSTEM

K820302 is the FDA 510(k) clearance for SURGIPEEL SELF-SEAL PACKAGING SYSTEM by Surgicot, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K820302 · Surgicot, Inc. · General Hospital
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Feb 1982
Decision
20d
Days
Class 2
Risk

K820302 is an FDA 510(k) clearance for the SURGIPEEL SELF-SEAL PACKAGING SYSTEM. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Surgicot, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 20 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 Surgicot, Inc. devices

Submission Details

510(k) Number K820302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1982
Decision Date February 24, 1982
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 102
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K820302.
TPN/HYPERALIMENTATION TRAY
K842644 · Deroyal Industries, Inc. · Nov 1984
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · Medline Industries, Inc. · Jul 1984
ECONOMY LINE OF TRAYS
K820589 · Abco Dealers, Inc. · Apr 1982
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981
GUARDIAN STERILIZATION WRAP
K803294 · Kimberly-Clark Corp. · Feb 1981
GUARDIAN PEEL POUCHES
K803293 · Kimberly-Clark Corp. · Jan 1981