Cleared Traditional

K131637 - ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)

K131637 is an FDA 510(k) clearance for ROTATION MEDICAL SOFT TISSUE STAPLE (RM..., manufactured by Rotation Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K131637 · Rotation Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
38d
Days
Class 2
Risk

K131637 is an FDA 510(k) clearance for the ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE). Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Rotation Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 12, 2013 after a review of 38 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rotation Medical, Inc. devices

FDA 510(k) Submission Details - K131637

510(k) Number K131637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2013
Decision Date July 12, 2013
Days to Decision 38 days
Submission Type Traditional
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
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 240
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K131637.
OPTIFIX ABSORBABLE FIXATION SYSTEM
K132134 · C.R. Bard, Inc. · Dec 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K132493 · Covidien, LLC · Oct 2013
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
K131663 · Ethicon Endo-Surgery, LLC · Oct 2013
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
K131511 · Changzhou Sinolinks Medical Innovation Co., Ltd. · Jul 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K131705 · Covidien, Formerly US Surgical A Divison of Tyco H · Jul 2013
DISPOSABLE CIRCULAR STAPLER
K131303 · Changzhou City Zhiye Medical Devices Institute Co. · Jun 2013