Cleared Traditional

K962605 - PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)

K962605 is an FDA 510(k) clearance for PRO-GUARD DOUBLE-DUTY STERILIZATION WRA..., manufactured by Surgicot, Inc.. The device is a Class 2 General Hospital device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K962605

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
Combination Product No
PCCP Authorized No
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.

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 268
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K962605.
CARR RIGID CONTAINER SYSTEM
K972138 · Carr Metal Products, Inc. · Nov 1997
SECURE-WRAP (TM) STERILIZATION WRAP
K971483 · American Threshold Industries, Inc. · Jun 1997
CYGNUS INSTRUMENT PROTECTORS
K964256 · Madison Polymeric Engineering · May 1997
BIOPSY TRAY
K970152 · Medcare Medical Group, Inc. · Mar 1997
JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
K961227 · J.J. Skinner, Inc. · Jun 1996
CPR DRESSING CHANGE TRAY
K960206 · Custom Pack Reliability · Apr 1996
K962605 · PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
Download PDF FDA Summary Surgicot, Inc.