Cleared Traditional

RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE (K993944) - FDA 510(k) Clearance

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

K993944 · Rita Medical Systems · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
13d
Days
Class 2
Risk

K993944 is an FDA 510(k) clearance for the RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, .... 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 December 2, 1999 after a review of 13 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 devices

Submission Details

510(k) Number K993944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1999
Decision Date December 02, 1999
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 2301
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K993944.
OsteoCool™ RF Ablation System
K253656 · Medtronic Sofamor Danek USA, Inc. · Jun 2026
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
K253918 · F Care Systems USA, LLC · Jun 2026
MILAN System
K253803 · Lumenis Be, Ltd. · Jun 2026
ENTire IRE System
K261202 · Entire Medical , Ltd. · May 2026
VIVA combo RF System
K252833 · Starmed Co., Ltd. · May 2026
LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
K253134 · Lagis Enterprise Co., Ltd. · May 2026