Cleared Traditional

K070887 - ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)

K070887 is an FDA 510(k) clearance for ENDOPATH LINEAR CUTTERS AND STAPLERS AN..., manufactured by Ethicon Endo-Surgery, LLC. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K070887 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
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May 2007
Decision
56d
Days
Class 2
Risk

K070887 is an FDA 510(k) clearance for the ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS .... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on May 25, 2007 after a review of 56 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 Ethicon Endo-Surgery, LLC devices

FDA 510(k) Submission Details - K070887

510(k) Number K070887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2007
Decision Date May 25, 2007
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
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 K070887.
IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
K073148 · Power Medical Interventions, Inc. · Dec 2007
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · United States Surgical, A Division of Tyco Healthc · Sep 2007
I45, I45S, I60, AND I60S
K071708 · Power Medical Interventions, Inc. · Sep 2007
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
K062869 · Ethicon Endo-Surgery, LLC · Feb 2007
POWER EXTENDERS MODEL# PEC200, PES200,PES200S
K063746 · Power Medical Interventions, Inc. · Jan 2007
NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS
K063075 · Power Medical Interventions, Inc. · Nov 2006