Cleared Special

K062100 - ARJOWRAP 47/100 AND 47/88

K062100 is an FDA 510(k) clearance for ARJOWRAP 47/100 AND 47/88, manufactured by Arjo Wiggins Medical, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Special 510(k) pathway after a 134-day FDA review.

K062100 · Arjo Wiggins Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
134d
Days
Class 2
Risk

K062100 is an FDA 510(k) clearance for the ARJOWRAP 47/100 AND 47/88. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Arjo Wiggins Medical, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on December 5, 2006 after a review of 134 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062100

510(k) Number K062100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date December 05, 2006
Days to Decision 134 days
Submission Type Special
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
5d slower than avg
Panel avg: 129d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

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 321
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K062100.
SELF SEAL STERILIZATION POUCH
K071886 · Shanghai Jianzhong Medical Packaging Co., Ltd. · Dec 2007
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
K071087 · STERIS Corporation · Oct 2007
STERILIZATION POUCH WITH INDICATORS
K062704 · Winner Industries (Shenzhen) Co., Ltd. · Jun 2007
AESCULAP STERILCONTAINER SYSTEM
K062510 · Aesculap · Nov 2006
CONMED LINVATEC INSTRUMENT STERILIZATION TRAY
K052992 · Conmed Linvatec · Oct 2006
GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES
K052665 · Granton Medical , Ltd. · Feb 2006
K062100 · ARJOWRAP 47/100 AND 47/88
Download PDF FDA Summary Arjo Wiggins Medical,…