Cleared Traditional

K160041 - Cobbra RF Tissue Dissector

K160041 is an FDA 510(k) clearance for Cobbra RF Tissue Dissector, manufactured by Elliquence, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K160041 · Elliquence, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
59d
Days
Class 2
Risk

K160041 is an FDA 510(k) clearance for the Cobbra RF Tissue Dissector. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Elliquence, LLC (Baldwin, US). The FDA issued a Cleared decision on March 7, 2016 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 878.4400 - 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: 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 Elliquence, LLC devices

FDA 510(k) Submission Details - K160041

510(k) Number K160041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2016
Decision Date March 07, 2016
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.

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 1286
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K160041.
Neptune E-SEP Smoke Evacuation Pencil
K160693 · Stryker Corporation · Apr 2016
PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
K153063 · Teleflexmedical, Inc. · Apr 2016
Barrx FLEX RFA Energy Generator
K160360 · Covidien, LLC · Apr 2016
THUNDERBEAT Open Fine Jaw
K151743 · Olympus Medical Systems Corp. · Feb 2016
Epix Electrosurgical Probe with Smoke Evacuation
K151480 · Applied Medical Resources · Feb 2016
InMode RF System
K151793 · Inmode MD , Ltd. · Feb 2016