Cleared Traditional

K121474 - DISPOSABLE LINEAR STAPLER

K121474 is an FDA 510(k) clearance for DISPOSABLE LINEAR STAPLER, manufactured by Changzhou Kangdi Medical Stapler Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K121474 · Changzhou Kangdi Medical Stapler Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
59d
Days
Class 2
Risk

K121474 is an FDA 510(k) clearance for the DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Changzhou Kangdi Medical Stapler Co., Ltd. (Echo, US). The FDA issued a Cleared decision on July 16, 2012 after a review of 59 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 Changzhou Kangdi Medical Stapler Co., Ltd. devices

FDA 510(k) Submission Details - K121474

510(k) Number K121474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2012
Decision Date July 16, 2012
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
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 184
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K121474.
ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
K123114 · Ethicon, Inc. · Feb 2013
PERMASORB DISPOSABLE FIXATION DEVICE
K123718 · C.R. Bard, Inc. · Jan 2013
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
K123109 · Covidien · Oct 2012
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
K121600 · Ethicon Endo-Surgery, LLC · Jul 2012
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
K112056 · Ethicon Endo-Surgery, LLC · Dec 2011
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
K111195 · Ethicon Endo-Surgery, Inc. · Aug 2011