FDA 510(k)

ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES

K-Number: K992408 · 1999-07-30

Decision Date1999-07-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR 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 1999-07-30 under 510(k) number K992408. 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 ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES?

ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K992408.

When did ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES receive FDA 510(k) clearance?

ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES received FDA 510(k) clearance on 1999-07-30, under 510(k) number K992408.

Who is the listed applicant for ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR 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 ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES?

The FDA product code for ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES is GEI.

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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

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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.