FDA 510(k)

NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337

K-Number: K083667 · 2009-02-02

Decision Date2009-02-02

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 is the device name listed in this FDA 510(k) record. The listed applicant is B-K Medical Aps. It received FDA 510(k) clearance on 2009-02-02 under 510(k) number K083667. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337?

NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 is a medical device that received FDA 510(k) clearance on 2009-02-02. The listed applicant is B-K Medical Aps. The 510(k) number is K083667.

When did NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 receive FDA 510(k) clearance?

NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 received FDA 510(k) clearance on 2009-02-02, under 510(k) number K083667.

Who is the listed applicant for NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337?

The FDA 510(k) record lists B-K Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337?

The FDA product code for NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 is ITX.

Related Clinical Trials

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Other records listing B-K Medical Aps as applicant

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Related Devices (Code: ITX)

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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.