Cleared Traditional

CARBODISSECTING ENDOSCOPE (K013680) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013680 · Endo Surgical Devices, Inc. · General & Plastic Surgery device
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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

Submission Details

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.

Device Classification

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 570
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K013680.
COBRA COOLED SURGICAL PROBE, MODEL 1596X
K021046 · Boston Scientific Corp · Apr 2002
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
K014207 · Aesculap, Inc. · Mar 2002
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · Aesculap, Inc. · Mar 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · Smith & Nephew, Inc. · Feb 2002
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
K013416 · Intuitive Surgical, Inc. · Jan 2002
BIPOLAR IRRIGATION FORCEPS
K012986 · Aesculap, Inc. · Oct 2001