FDA 510(k)

ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE

K-Number: K954439 · 1995-12-18

Decision Date1995-12-18

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE 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 1995-12-18 under 510(k) number K954439. 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 TAC 1000 MONOPOLAR CAUTERY PROBE?

ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K954439.

When did ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE receive FDA 510(k) clearance?

ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE received FDA 510(k) clearance on 1995-12-18, under 510(k) number K954439.

Who is the listed applicant for ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE?

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 TAC 1000 MONOPOLAR CAUTERY PROBE?

The FDA product code for ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE 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.