FDA 510(k)

ORATEC MODEL ENDOTAC PROBE

K-Number: K972358 · 1998-01-23

Decision Date1998-01-23

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORATEC MODEL ENDOTAC 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 1998-01-23 under 510(k) number K972358. 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 MODEL ENDOTAC PROBE?

ORATEC MODEL ENDOTAC PROBE is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K972358.

When did ORATEC MODEL ENDOTAC PROBE receive FDA 510(k) clearance?

ORATEC MODEL ENDOTAC PROBE received FDA 510(k) clearance on 1998-01-23, under 510(k) number K972358.

Who is the listed applicant for ORATEC MODEL ENDOTAC 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 MODEL ENDOTAC PROBE?

The FDA product code for ORATEC MODEL ENDOTAC 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.