FDA 510(k)

OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS

K-Number: K112214 · 2011-11-17

ApplicantSt. Jude Medical Neuromodulation

Decision Date2011-11-17

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical Neuromodulation. It received FDA 510(k) clearance on 2011-11-17 under 510(k) number K112214. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS?

OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS is a medical device that received FDA 510(k) clearance on 2011-11-17. The listed applicant is St. Jude Medical Neuromodulation. The 510(k) number is K112214.

When did OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS receive FDA 510(k) clearance?

OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS received FDA 510(k) clearance on 2011-11-17, under 510(k) number K112214.

Who is the listed applicant for OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS?

The FDA 510(k) record lists St. Jude Medical Neuromodulation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS?

The FDA product code for OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS is GZB.

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Other records listing St. Jude Medical Neuromodulation as applicant

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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.