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FDA 510(k)

NEEDLEPOINT GUARD

K-Number: K892405 · 1989-05-30

ApplicantUrological Assoc. of Grand Island, P.C.
Decision Date1989-05-30
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEEDLEPOINT GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Urological Assoc. of Grand Island, P.C.. It received FDA 510(k) clearance on 1989-05-30 under 510(k) number K892405. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLEPOINT GUARD?

NEEDLEPOINT GUARD is a medical device that received FDA 510(k) clearance on 1989-05-30. The listed applicant is Urological Assoc. of Grand Island, P.C.. The 510(k) number is K892405.

When did NEEDLEPOINT GUARD receive FDA 510(k) clearance?

NEEDLEPOINT GUARD received FDA 510(k) clearance on 1989-05-30, under 510(k) number K892405.

Who is the listed applicant for NEEDLEPOINT GUARD?

The FDA 510(k) record lists Urological Assoc. of Grand Island, P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEEDLEPOINT GUARD?

The FDA product code for NEEDLEPOINT GUARD is FMF.

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Related Devices (Code: FMF)

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

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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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