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FDA 510(k)

ADG BONE BIOPSY SYSTEM

K-Number: K890722 · 1989-09-21

ApplicantAmerican Design Group, Inc.
Decision Date1989-09-21
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADG BONE BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Design Group, Inc.. It received FDA 510(k) clearance on 1989-09-21 under 510(k) number K890722. 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 ADG BONE BIOPSY SYSTEM?

ADG BONE BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-21. The listed applicant is American Design Group, Inc.. The 510(k) number is K890722.

When did ADG BONE BIOPSY SYSTEM receive FDA 510(k) clearance?

ADG BONE BIOPSY SYSTEM received FDA 510(k) clearance on 1989-09-21, under 510(k) number K890722.

Who is the listed applicant for ADG BONE BIOPSY SYSTEM?

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

What is the FDA product code for ADG BONE BIOPSY SYSTEM?

The FDA product code for ADG BONE BIOPSY SYSTEM is GDM.

Related Clinical Trials

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.

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Other records listing American Design Group, 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.

K911717ADG INTRAMEDULLARY BONE PLUG - VENTEDK902615ADG BONE PLUG

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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