FDA 510(k)

NUCLEOTOMY INTRADISCAL CATHETER

K-Number: K013622 · 2002-01-31

Decision Date2002-01-31

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NUCLEOTOMY INTRADISCAL CATHETER 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 2002-01-31 under 510(k) number K013622. 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 NUCLEOTOMY INTRADISCAL CATHETER?

NUCLEOTOMY INTRADISCAL CATHETER is a medical device that received FDA 510(k) clearance on 2002-01-31. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K013622.

When did NUCLEOTOMY INTRADISCAL CATHETER receive FDA 510(k) clearance?

NUCLEOTOMY INTRADISCAL CATHETER received FDA 510(k) clearance on 2002-01-31, under 510(k) number K013622.

Who is the listed applicant for NUCLEOTOMY INTRADISCAL CATHETER?

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 NUCLEOTOMY INTRADISCAL CATHETER?

The FDA product code for NUCLEOTOMY INTRADISCAL CATHETER 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.