Cleared Special

K103269 - PATCHASSIST LARGE

K103269 is an FDA 510(k) clearance for PATCHASSIST LARGE, manufactured by Polytouch Medical, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code ORQ cleared through the Special 510(k) pathway after a 19-day FDA review.

K103269 · Polytouch Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
19d
Days
Class 2
Risk

K103269 is an FDA 510(k) clearance for the PATCHASSIST LARGE. Classified as Mesh, Surgical, Deployer (product code ORQ), Class II - Special Controls.

Submitted by Polytouch Medical, Ltd. (Providence, US). The FDA issued a Cleared decision on November 23, 2010 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery 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. Low regulatory complexity profile. 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 - K103269

510(k) Number K103269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2010
Decision Date November 23, 2010
Days to Decision 19 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

ORQ Device Classification - Class 2, Special Controls

Product Code ORQ Mesh, Surgical, Deployer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Soft Tissue Defects (e.g. Hernia Repair).
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 & Plastic Surgery devices follow this clearance model.

K103269 · PATCHASSIST LARGE
Download PDF FDA Summary Polytouch Medical, Lt…