FDA 510(k)

ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002

K-Number: K993967 · 1999-12-17

Decision Date1999-12-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 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 1999-12-17 under 510(k) number K993967. 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 SPINECATH INTRADISCAL CATHETER, MODEL 920002?

ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 is a medical device that received FDA 510(k) clearance on 1999-12-17. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K993967.

When did ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 receive FDA 510(k) clearance?

ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 received FDA 510(k) clearance on 1999-12-17, under 510(k) number K993967.

Who is the listed applicant for ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002?

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 SPINECATH INTRADISCAL CATHETER, MODEL 920002?

The FDA product code for ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 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.