Cleared Special

K994333 - ORA-50 ELECTROTHERMAL SYSTEM AND ACCESS...

K994333 is an FDA 510(k) clearance for ORA-50 ELECTROTHERMAL SYSTEM AND ACCESS..., manufactured by Oratec Interventions, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 26-day FDA review.

K994333 · Oratec Interventions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
26d
Days
Class 2
Risk

K994333 is an FDA 510(k) clearance for the ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Oratec Interventions, Inc. (Menlo Park, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 26 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Oratec Interventions, Inc. devices

FDA 510(k) Submission Details - K994333

510(k) Number K994333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date January 18, 2000
Days to Decision 26 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
89d faster than avg
Panel avg: 115d · This submission: 26d
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 1260
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K994333.
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS
K000074 · Arthrocare Corp. · Feb 2000
ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
K992805 · Oratec Interventions, Inc. · Feb 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS
K000044 · Arthrocare Corp. · Feb 2000
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
K993655 · Xomed, Inc. · Dec 1999
ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002
K993967 · Oratec Interventions, Inc. · Dec 1999
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDS
K992581 · Arthrocare Corp. · Dec 1999