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FDA 510(k)

BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070

K-Number: K090217 · 2009-04-23

ApplicantColoplast A/S
Decision Date2009-04-23
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2009-04-23 under 510(k) number K090217. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070?

BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 is a medical device that received FDA 510(k) clearance on 2009-04-23. The listed applicant is Coloplast A/S. The 510(k) number is K090217.

When did BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 receive FDA 510(k) clearance?

BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 received FDA 510(k) clearance on 2009-04-23, under 510(k) number K090217.

Who is the listed applicant for BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070?

The FDA product code for BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 is FBK.

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Related Devices (Code: FBK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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