Cleared Traditional

K013680 - CARBODISSECTING ENDOSCOPE

K013680 is an FDA 510(k) clearance for CARBODISSECTING ENDOSCOPE, manufactured by Endo Surgical Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K013680 · Endo Surgical Devices, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
117d
Days
Class 2
Risk

K013680 is an FDA 510(k) clearance for the CARBODISSECTING ENDOSCOPE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Endo Surgical Devices, Inc. (Hopkonton, US). The FDA issued a Cleared decision on March 4, 2002 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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 Endo Surgical Devices, Inc. devices

FDA 510(k) Submission Details - K013680

510(k) Number K013680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date March 04, 2002
Days to Decision 117 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
2d slower than avg
Panel avg: 115d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1676
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K013680.
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
K014207 · Aesculap, Inc. · Mar 2002
ARTHROCARE CONTROLLER
K020557 · Arthrocare Corp. · Mar 2002
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · Aesculap, Inc. · Mar 2002
AARON REUSABLE ELECTROSURGICAL ELECTRODE
K014201 · Aaron Medical Industries · Feb 2002
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
K013904 · Baylis Medical Co., Inc. · Feb 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · Smith & Nephew, Inc. · Feb 2002