FDA 510(k)

MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY

K-Number: K984185 · 1998-12-16

Decision Date1998-12-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY 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 1998-12-16 under 510(k) number K984185. 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 MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY?

MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K984185.

When did MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY receive FDA 510(k) clearance?

MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY received FDA 510(k) clearance on 1998-12-16, under 510(k) number K984185.

Who is the listed applicant for MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY?

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 MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY?

The FDA product code for MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY is GEI.

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Official Source

View on FDA Database →

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