FDA 510(k)

ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR

K-Number: K964071 · 1996-12-12

Decision Date1996-12-12

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR 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 1996-12-12 under 510(k) number K964071. 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 ORA 50 ELECTROTHERMAL GENERATOR?

ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR is a medical device that received FDA 510(k) clearance on 1996-12-12. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K964071.

When did ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR receive FDA 510(k) clearance?

ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR received FDA 510(k) clearance on 1996-12-12, under 510(k) number K964071.

Who is the listed applicant for ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR?

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 ORA 50 ELECTROTHERMAL GENERATOR?

The FDA product code for ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR is GEI.

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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.