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FDA 510(k)

BONE MARROW BIOPSY DEVICE

K-Number: K772293 · 1978-01-03

ApplicantRadiation Development Co., Inc.
Decision Date1978-01-03
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BONE MARROW BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Radiation Development Co., Inc.. It received FDA 510(k) clearance on 1978-01-03 under 510(k) number K772293. 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 BONE MARROW BIOPSY DEVICE?

BONE MARROW BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 1978-01-03. The listed applicant is Radiation Development Co., Inc.. The 510(k) number is K772293.

When did BONE MARROW BIOPSY DEVICE receive FDA 510(k) clearance?

BONE MARROW BIOPSY DEVICE received FDA 510(k) clearance on 1978-01-03, under 510(k) number K772293.

Who is the listed applicant for BONE MARROW BIOPSY DEVICE?

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

What is the FDA product code for BONE MARROW BIOPSY DEVICE?

The FDA product code for BONE MARROW BIOPSY DEVICE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Radiation Development Co., 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.

K771574LEE ASPIRATION NEEDLE

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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