Cleared Special

K143147 - Gemini Bonded Sterilization Wrap

K143147 is an FDA 510(k) clearance for Gemini Bonded Sterilization Wrap, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Special 510(k) pathway after a 185-day FDA review.

K143147 · Medline Industries, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
185d
Days
Class 2
Risk

K143147 is an FDA 510(k) clearance for the Gemini Bonded Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on May 7, 2015 after a review of 185 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. 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 - K143147

510(k) Number K143147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2014
Decision Date May 07, 2015
Days to Decision 185 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
56d slower than avg
Panel avg: 129d · This submission: 185d
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 268
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K143147.
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K141826 · Symmetry Medical Inc- Manchester · Apr 2015
STERILIZATION POUCH/ROLL MADE WITH TYVEK
K133838 · Sigma Medical Supplies Corp. · Mar 2015
K143147 · Gemini Bonded Sterilization Wrap
Download PDF FDA Summary Medline Industries, I…