Cleared Traditional

K972358 - ORATEC MODEL ENDOTAC PROBE

K972358 is an FDA 510(k) clearance for ORATEC MODEL ENDOTAC PROBE, manufactured by Oratec Interventions, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K972358 · Oratec Interventions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
212d
Days
Class 2
Risk

K972358 is an FDA 510(k) clearance for the ORATEC MODEL ENDOTAC PROBE. 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 23, 1998 after a review of 212 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Oratec Interventions, Inc. devices

FDA 510(k) Submission Details - K972358

510(k) Number K972358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1997
Decision Date January 23, 1998
Days to Decision 212 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 115d · This submission: 212d
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 1259
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K972358.
ORATEC SPINECATH INTRADISCAL CATHETER
K974464 · Oratec Interventions, Inc. · Mar 1998
ELMED ESU 120 M/M DIGITAL
K974793 · Elmed, Inc. · Mar 1998
AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240
K980366 · Aaron Medical Industries · Feb 1998
VAPR
K974022 · Mitek Products · Jan 1998
ARTHROCARE SINUS ELECTROSURGERY SYSTEM
K973478 · Arthrocare Corp. · Jan 1998
UNIVERSALPLUS LAPAROSCOPIC ABC/ELECTROSURGICAL ELECTRODE
K973890 · Conmedcorp · Jan 1998