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FDA 510(k)

ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE

K-Number: K874585 · 1987-12-02

ApplicantAngiomed U.S., Inc.
Decision Date1987-12-02
Product CodeDWO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Angiomed U.S., Inc.. It received FDA 510(k) clearance on 1987-12-02 under 510(k) number K874585. The device is classified under product code DWO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE?

ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1987-12-02. The listed applicant is Angiomed U.S., Inc.. The 510(k) number is K874585.

When did ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE receive FDA 510(k) clearance?

ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE received FDA 510(k) clearance on 1987-12-02, under 510(k) number K874585.

Who is the listed applicant for ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE?

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

What is the FDA product code for ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE?

The FDA product code for ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE is DWO.

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Other records listing Angiomed U.S., Inc. as applicant

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.

K874771ANGIOMED INTRODUCING SETSK864225ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENTK863386VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETSK862805ANGIOMED VAC-U-CUT BIOPSY NEEDLEK863446ANGIOMED HIGH PRESSURE CONNECTORSK854910ANGIOFLOW

View all 24 devices →

Related Devices (Code: DWO)

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.

K933364PROMED BIOPSY NEEDLEVlv Associates, Inc.K921418ULTRA-CORE BIOPSY NEEDLESMedical Device Technologies, Inc.K913815AUTOMATED BIOPSY DEVICE, MODIFICATIONHart Enterprises, Inc.K890925MANAN BONE MARROW BIOPSY NEEDLEManan Medical Products, Inc.K885145MEDSURG GREENE NEEDLEMedsurg Industries, Inc.K885149NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICEHart Enterprises, Inc.

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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