FDA 510(k)

ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE

K-Number: K973158 · 1997-11-05

Decision Date1997-11-05

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Oratec Interventions, Inc.. It received FDA 510(k) clearance on 1997-11-05 under 510(k) number K973158. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE?

ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE is a medical device that received FDA 510(k) clearance on 1997-11-05. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K973158.

When did ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE receive FDA 510(k) clearance?

ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE received FDA 510(k) clearance on 1997-11-05, under 510(k) number K973158.

Who is the listed applicant for ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE?

The FDA 510(k) record lists Oratec Interventions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE?

The FDA product code for ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE is GEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Oratec Interventions, Inc. as applicant

K013622NUCLEOTOMY INTRADISCAL CATHETER K003198VULCAN TAC PROBES, MODEL 911XXX K003893VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X K000691VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS K992805ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)K994333ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES

View all 24 devices →

Related Devices (Code: GEI)

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.