Cleared Traditional

K962605 - PRO-GUARD DOUBLE-DUTY STERILIZATION WRA...

K962605 is the FDA 510(k) clearance for PRO-GUARD DOUBLE-DUTY STERILIZATION WRA... by Surgicot, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K962605 · Surgicot, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
252d
Days
Class 2
Risk

K962605 is an FDA 510(k) clearance for the PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE). Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Surgicot, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 252 days - an extended review 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: 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 Surgicot, Inc. devices

Submission Details

510(k) Number K962605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1996
Decision Date March 11, 1997
Days to Decision 252 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 129d · This submission: 252d
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 K962605.
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K960204 · GE Medical Systems · Feb 1996
G.E. STERILE, STANDARD BIOPSY TRAY
K960141 · GE Medical Systems · Feb 1996
G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY
K960201 · GE Medical Systems · Feb 1996