Cleared Traditional

K031257 - RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR

K031257 is an FDA 510(k) clearance for RITA MODEL 1500X ELECTROSURGICAL RF GEN..., manufactured by Rita Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K031257 · Rita Medical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
11d
Days
Class 2
Risk

K031257 is an FDA 510(k) clearance for the RITA MODEL 1500X 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, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 11 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 Rita Medical Systems, Inc. devices

FDA 510(k) Submission Details - K031257

510(k) Number K031257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2003
Decision Date May 02, 2003
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 1575
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K031257.
CODMAN ISOCOOL BIPOLAR FORCEPS
K023566 · Codman & Shurtleff, Inc. · May 2003
THERMACOOL TC SYSTEM
K031046 · Thermage, Inc. · May 2003
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
K031285 · Megadyne Medical Products, Inc. · May 2003
ARTHROCARE PERCD SPINEWAND
K030954 · Arthrocare Corp. · Apr 2003
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
K030362 · Leonhard Lang GmbH · Apr 2003
RADIONICS SINGLE USE GROUND PAD (DGP-HP)
K030697 · Radionics, Inc. · Apr 2003