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FDA 510(k)

PROMED BIOPSY NEEDLE

K-Number: K933364 · 1994-02-15

ApplicantVlv Associates, Inc.
Decision Date1994-02-15
Product CodeDWO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROMED BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Vlv Associates, Inc.. It received FDA 510(k) clearance on 1994-02-15 under 510(k) number K933364. 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 PROMED BIOPSY NEEDLE?

PROMED BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1994-02-15. The listed applicant is Vlv Associates, Inc.. The 510(k) number is K933364.

When did PROMED BIOPSY NEEDLE receive FDA 510(k) clearance?

PROMED BIOPSY NEEDLE received FDA 510(k) clearance on 1994-02-15, under 510(k) number K933364.

Who is the listed applicant for PROMED BIOPSY NEEDLE?

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

What is the FDA product code for PROMED BIOPSY NEEDLE?

The FDA product code for PROMED BIOPSY NEEDLE is DWO.

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Other records listing Vlv Associates, 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.

K972957SA-EF MULTI-LUMEN EXTENSION SETK964876SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SETK955783VLV SA.EF INFUSION PORT EXTENSION SETSK953791VLV SA EF INFUSION PORTK945592VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGEK940406DISPOSABLE, AMBULATORY, INFUSION PUMPS

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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.

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.K882013SOFT TISSUE BIOPSY DEVICEOcean Medical Products, Ltd.

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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