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FDA 510(k)

Medispine - Spinal Needle, Glospine - Spinal Needle

K-Number: K212982 · 2022-07-29

ApplicantGlobal Medikit Limited
Decision Date2022-07-29
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Medispine - Spinal Needle, Glospine - Spinal Needle is the device name listed in this FDA 510(k) record. The listed applicant is Global Medikit Limited. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K212982. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medispine - Spinal Needle, Glospine - Spinal Needle?

Medispine - Spinal Needle, Glospine - Spinal Needle is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Global Medikit Limited. The 510(k) number is K212982.

When did Medispine - Spinal Needle, Glospine - Spinal Needle receive FDA 510(k) clearance?

Medispine - Spinal Needle, Glospine - Spinal Needle received FDA 510(k) clearance on 2022-07-29, under 510(k) number K212982.

Who is the listed applicant for Medispine - Spinal Needle, Glospine - Spinal Needle?

The FDA 510(k) record lists Global Medikit Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medispine - Spinal Needle, Glospine - Spinal Needle?

The FDA product code for Medispine - Spinal Needle, Glospine - Spinal Needle is BSP.

Other records listing Global Medikit Limited 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.

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