Cleared Traditional

K760662 - STERIL.WRAP(#221901

K760662 is the FDA 510(k) clearance for STERIL.WRAP(#221901 by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K760662 · C.R. Bard, Inc. · General Hospital
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Dec 1976
Decision
104d
Days
Class 2
Risk

K760662 is an FDA 510(k) clearance for the STERIL.WRAP(#221901,2,3,4,5,6,7,8,9). Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K760662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1976
Decision Date December 30, 1976
Days to Decision 104 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 129d · This submission: 104d
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.