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FDA 510(k)

NEEDLE SHIELD NEEDLE DISPOSAL UNIT

K-Number: K881390 · 1988-04-29

ApplicantXenetics Biomedical, Inc.
Decision Date1988-04-29
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEEDLE SHIELD NEEDLE DISPOSAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Xenetics Biomedical, Inc.. It received FDA 510(k) clearance on 1988-04-29 under 510(k) number K881390. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE SHIELD NEEDLE DISPOSAL UNIT?

NEEDLE SHIELD NEEDLE DISPOSAL UNIT is a medical device that received FDA 510(k) clearance on 1988-04-29. The listed applicant is Xenetics Biomedical, Inc.. The 510(k) number is K881390.

When did NEEDLE SHIELD NEEDLE DISPOSAL UNIT receive FDA 510(k) clearance?

NEEDLE SHIELD NEEDLE DISPOSAL UNIT received FDA 510(k) clearance on 1988-04-29, under 510(k) number K881390.

Who is the listed applicant for NEEDLE SHIELD NEEDLE DISPOSAL UNIT?

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

What is the FDA product code for NEEDLE SHIELD NEEDLE DISPOSAL UNIT?

The FDA product code for NEEDLE SHIELD NEEDLE DISPOSAL UNIT is FPA.

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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