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FDA 510(k)

CORE BIOPSY NEEDLE, CATALOG CODE #54006

K-Number: K891537 · 1989-04-18

ApplicantDlp, Inc.
Decision Date1989-04-18
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CORE BIOPSY NEEDLE, CATALOG CODE #54006 is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1989-04-18 under 510(k) number K891537. 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 CORE BIOPSY NEEDLE, CATALOG CODE #54006?

CORE BIOPSY NEEDLE, CATALOG CODE #54006 is a medical device that received FDA 510(k) clearance on 1989-04-18. The listed applicant is Dlp, Inc.. The 510(k) number is K891537.

When did CORE BIOPSY NEEDLE, CATALOG CODE #54006 receive FDA 510(k) clearance?

CORE BIOPSY NEEDLE, CATALOG CODE #54006 received FDA 510(k) clearance on 1989-04-18, under 510(k) number K891537.

Who is the listed applicant for CORE BIOPSY NEEDLE, CATALOG CODE #54006?

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

What is the FDA product code for CORE BIOPSY NEEDLE, CATALOG CODE #54006?

The FDA product code for CORE BIOPSY NEEDLE, CATALOG CODE #54006 is GDM.

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Other records listing Dlp, 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.

K973485CLEARVIEW BLOWER/MISTERK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETK950754MACRO SUCTION TUBE MODEL NO 10061K934215CONTAIN-ORK915268CATHETER TWO STAGE VENOUS RETURN

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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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