Cleared Traditional

K082962 - TIVAMED COOLED RF SYSTEM, MODEL 78001

K082962 is an FDA 510(k) clearance for TIVAMED COOLED RF SYSTEM, manufactured by Tivamed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K082962 · Tivamed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
62d
Days
Class 2
Risk

K082962 is an FDA 510(k) clearance for the TIVAMED COOLED RF SYSTEM, MODEL 78001. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Tivamed, Inc. (Los Altos, US). The FDA issued a Cleared decision on December 4, 2008 after a review of 62 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.

FDA 510(k) Submission Details - K082962

510(k) Number K082962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2008
Decision Date December 04, 2008
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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 2292
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K082962.
RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
K082902 · Rz Medizintechnik GmbH · Dec 2008
MODIFICATION TO ARTHROCARE ARTHROWANDS
K083306 · Arthrocare Corp. · Dec 2008
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001
K083013 · Gyrus Acmi, Inc. · Dec 2008
PULSAR GENERATOR, PEAK PLASMABLADE
K082786 · Peak Surgical, Inc. · Dec 2008
SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE
K082568 · Bovie Medical · Nov 2008
ARTHROCARE ARTHROWANDS
K082980 · Arthrocare Corp. · Nov 2008
K082962 · TIVAMED COOLED RF SYSTEM, MODEL 78001
Download PDF FDA Summary Tivamed, Inc.