Cleared Special

K111064 - TIGERPAW SYSTEM II

K111064 is an FDA 510(k) clearance for TIGERPAW SYSTEM II, manufactured by Laax, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 30-day FDA review.

K111064 · Laax, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
30d
Days
Class 2
Risk

K111064 is an FDA 510(k) clearance for the TIGERPAW SYSTEM II. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Laax, Inc. (Orinda, US). The FDA issued a Cleared decision on May 18, 2011 after a review of 30 days - a notably fast clearance cycle.

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. 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.

View all Laax, Inc. devices

FDA 510(k) Submission Details - K111064

510(k) Number K111064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2011
Decision Date May 18, 2011
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 186
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K111064.
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
K111195 · Ethicon Endo-Surgery, Inc. · Aug 2011
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
K111111 · Ethicon Endo-Surgery, LLC · Jun 2011
SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
K111153 · C.R. Bard, Inc. · May 2011
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
K103672 · Ethicon Endo-Surgery, LLC · Apr 2011
ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
K110385 · Ethicon Endo-Surgery, Inc. · Mar 2011
REUSABLE LINEAR STAPLER HANDLE
K110049 · Ethicon Endo-Surgery, LLC · Feb 2011