FDA 510(k)

INTRADISCAL THERAPY NEEDLE

K-Number: K831610 · 1983-07-12

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1983-07-12

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INTRADISCAL THERAPY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831610. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRADISCAL THERAPY NEEDLE?

INTRADISCAL THERAPY NEEDLE is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K831610.

When did INTRADISCAL THERAPY NEEDLE receive FDA 510(k) clearance?

INTRADISCAL THERAPY NEEDLE received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831610.

Who is the listed applicant for INTRADISCAL THERAPY NEEDLE?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRADISCAL THERAPY NEEDLE?

The FDA product code for INTRADISCAL THERAPY NEEDLE is FMI.

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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.