FDA 510(k)

BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST

K-Number: K022415 · 2002-10-11

Decision Date2002-10-11

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST is the device name listed in this FDA 510(k) record. The listed applicant is Waismed, Ltd.. It received FDA 510(k) clearance on 2002-10-11 under 510(k) number K022415. 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 BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST?

BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST is a medical device that received FDA 510(k) clearance on 2002-10-11. The listed applicant is Waismed, Ltd.. The 510(k) number is K022415.

When did BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST receive FDA 510(k) clearance?

BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST received FDA 510(k) clearance on 2002-10-11, under 510(k) number K022415.

Who is the listed applicant for BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST?

The FDA 510(k) record lists Waismed, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST?

The FDA product code for BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST is FMI.

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Other records listing Waismed, Ltd. 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.