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FDA 510(k)

ULTRA-CORE BIOPSY NEEDLES

K-Number: K921418 · 1992-06-19

ApplicantMedical Device Technologies, Inc.
Decision Date1992-06-19
Product CodeDWO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRA-CORE BIOPSY NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Technologies, Inc.. It received FDA 510(k) clearance on 1992-06-19 under 510(k) number K921418. 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 ULTRA-CORE BIOPSY NEEDLES?

ULTRA-CORE BIOPSY NEEDLES is a medical device that received FDA 510(k) clearance on 1992-06-19. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K921418.

When did ULTRA-CORE BIOPSY NEEDLES receive FDA 510(k) clearance?

ULTRA-CORE BIOPSY NEEDLES received FDA 510(k) clearance on 1992-06-19, under 510(k) number K921418.

Who is the listed applicant for ULTRA-CORE BIOPSY NEEDLES?

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

What is the FDA product code for ULTRA-CORE BIOPSY NEEDLES?

The FDA product code for ULTRA-CORE BIOPSY NEEDLES is DWO.

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Other records listing Medical Device Technologies, 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.

K101832BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENTK053518INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHORK051421INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHORK050873CANALIZER HYDROPHILIC GUIDE WIREK043523INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLEK042464V-CORE FULL CORE BREAST BIOPSY INSTRUMENT

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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.

K933364PROMED BIOPSY NEEDLEVlv Associates, 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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