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FDA 510(k)

ANGIOMED VAC-U-CUT BIOPSY NEEDLE

K-Number: K862805 · 1986-09-29

ApplicantAngiomed U.S., Inc.
Decision Date1986-09-29
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANGIOMED VAC-U-CUT 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 1986-09-29 under 510(k) number K862805. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIOMED VAC-U-CUT BIOPSY NEEDLE?

ANGIOMED VAC-U-CUT BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Angiomed U.S., Inc.. The 510(k) number is K862805.

When did ANGIOMED VAC-U-CUT BIOPSY NEEDLE receive FDA 510(k) clearance?

ANGIOMED VAC-U-CUT BIOPSY NEEDLE received FDA 510(k) clearance on 1986-09-29, under 510(k) number K862805.

Who is the listed applicant for ANGIOMED VAC-U-CUT 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 VAC-U-CUT BIOPSY NEEDLE?

The FDA product code for ANGIOMED VAC-U-CUT BIOPSY NEEDLE is GDM.

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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 SETSK874585ANGIOMED OSTY-CUT BONE BIOPSY NEEDLEK864225ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENTK863386VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETSK863446ANGIOMED HIGH PRESSURE CONNECTORSK854910ANGIOFLOW

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Related Devices (Code: GDM)

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.

K071732MARROWMINERStemcor Systems, Inc.K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare CorpK953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.

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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