Cleared Special

K003676 - RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR

K003676 is an FDA 510(k) clearance for RITA MODEL 2500 ELECTROSURGICAL RF GENE..., manufactured by Rita Medical Systems. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 131-day FDA review.

K003676 · Rita Medical Systems · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
131d
Days
Class 2
Risk

K003676 is an FDA 510(k) clearance for the RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Rita Medical Systems (Mountain View, US). The FDA issued a Cleared decision on April 9, 2001 after a review of 131 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003676

510(k) Number K003676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2000
Decision Date April 09, 2001
Days to Decision 131 days
Submission Type Special
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
16d slower than avg
Panel avg: 115d · This submission: 131d
Pathway characteristics
Modification to existing cleared device.

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 2233
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K003676.
BIPOLAR TRIGGER-FLEX PROBE
K003126 · Ellman Intl., Inc. · Apr 2001
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS
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ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150
K002981 · Ethicon Endo-Surgery, Inc. · Apr 2001
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
K010265 · Baylis Medical Co., Inc. · Apr 2001
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR
K010010 · Valleylab, Inc. · Apr 2001
BIPOLAR COAGULATION SYSTEM
K010112 · Enable Medical Corp. · Apr 2001
K003676 · RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR
Download PDF FDA Summary Rita Medical Systems