Cleared Special

K153202 - iMESH Tacker

K153202 is an FDA 510(k) clearance for iMESH Tacker, manufactured by Thd Lap. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 141-day FDA review.

K153202 · Thd Lap · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
141d
Days
Class 2
Risk

K153202 is an FDA 510(k) clearance for the iMESH Tacker. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Thd Lap (Tel Aviv, IL). The FDA issued a Cleared decision on March 24, 2016 after a review of 141 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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. 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.

View all Thd Lap devices

FDA 510(k) Submission Details - K153202

510(k) Number K153202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2015
Decision Date March 24, 2016
Days to Decision 141 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Modification to existing cleared device.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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.

Regulatory Peers - GDW Staple, Implantable

All 184
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