Cleared Traditional

K080839 - ECHELON GRAY CARTRIDGE, MODEL ERC45M

K080839 is an FDA 510(k) clearance for ECHELON GRAY CARTRIDGE, 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 57-day FDA review.

K080839 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
57d
Days
Class 2
Risk

K080839 is an FDA 510(k) clearance for the ECHELON GRAY CARTRIDGE, MODEL ERC45M. 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 21, 2008 after a review of 57 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 - K080839

510(k) Number K080839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2008
Decision Date May 21, 2008
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 K080839.
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
K083527 · Power Medical Interventions, Inc. · Dec 2008
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
K081826 · Power Medical Interventions, Inc. · Jul 2008
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
K081146 · Ethicon Endo-Surgery, LLC · Jun 2008
IDRIVES, IDRIVEC, IDRIVEF
K073001 · Power Medical Interventions, Inc. · Dec 2007
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