Cleared Traditional

K120179 - REACH SURGICAL STAPLERS

K120179 is an FDA 510(k) clearance for REACH SURGICAL STAPLERS, manufactured by Reach Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K120179 · Reach Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
124d
Days
Class 2
Risk

K120179 is an FDA 510(k) clearance for the REACH SURGICAL STAPLERS. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Reach Surgical, Inc. (Shanghai, CN). The FDA issued a Cleared decision on May 23, 2012 after a review of 124 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Reach Surgical, Inc. devices

FDA 510(k) Submission Details - K120179

510(k) Number K120179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2012
Decision Date May 23, 2012
Days to Decision 124 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
9d slower than avg
Panel avg: 115d · This submission: 124d
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 241
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K120179.
IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
K121510 · Covidien, Formerly US Surgical A Divison of Tyco H · Jul 2012
DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
K121474 · Changzhou Kangdi Medical Stapler Co., Ltd. · Jul 2012
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
K121600 · Ethicon Endo-Surgery, LLC · Jul 2012
INSORB ABSORBALBE STAPLE
K120373 · Incisive Surgical, Inc. · Mar 2012
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
K120258 · Covidien, Formerly US Surgical A Divison of Tyco H · Feb 2012
AMID STAPLER
K120268 · Safestich Medical, LLC · Feb 2012