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FDA 510(k)

WHOLEY (TM) BIOPSY DEVICE

K-Number: K874928 · 1987-12-30

ApplicantMedrad, Inc.
Decision Date1987-12-30
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WHOLEY (TM) BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 1987-12-30 under 510(k) number K874928. 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 WHOLEY (TM) BIOPSY DEVICE?

WHOLEY (TM) BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 1987-12-30. The listed applicant is Medrad, Inc.. The 510(k) number is K874928.

When did WHOLEY (TM) BIOPSY DEVICE receive FDA 510(k) clearance?

WHOLEY (TM) BIOPSY DEVICE received FDA 510(k) clearance on 1987-12-30, under 510(k) number K874928.

Who is the listed applicant for WHOLEY (TM) BIOPSY DEVICE?

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

What is the FDA product code for WHOLEY (TM) BIOPSY DEVICE?

The FDA product code for WHOLEY (TM) BIOPSY DEVICE is GDM.

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Other records listing Medrad, Inc. as applicant

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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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