FDA 510(k)

ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)

K-Number: K992805 · 2000-02-04

Decision Date2000-02-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) 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 2000-02-04 under 510(k) number K992805. 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 ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)?

ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) is a medical device that received FDA 510(k) clearance on 2000-02-04. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K992805.

When did ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) receive FDA 510(k) clearance?

ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) received FDA 510(k) clearance on 2000-02-04, under 510(k) number K992805.

Who is the listed applicant for ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)?

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 ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)?

The FDA product code for ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) is GEI.

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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 K994333ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES K993967ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002

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Official Source

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