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FDA 510(k)

BIOACCESS MARROW HARVEST SYSTEM

K-Number: K971114 · 1997-06-03

ApplicantBioaccess, Inc.
Decision Date1997-06-03
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOACCESS MARROW HARVEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bioaccess, Inc.. It received FDA 510(k) clearance on 1997-06-03 under 510(k) number K971114. 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 BIOACCESS MARROW HARVEST SYSTEM?

BIOACCESS MARROW HARVEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is Bioaccess, Inc.. The 510(k) number is K971114.

When did BIOACCESS MARROW HARVEST SYSTEM receive FDA 510(k) clearance?

BIOACCESS MARROW HARVEST SYSTEM received FDA 510(k) clearance on 1997-06-03, under 510(k) number K971114.

Who is the listed applicant for BIOACCESS MARROW HARVEST SYSTEM?

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

What is the FDA product code for BIOACCESS MARROW HARVEST SYSTEM?

The FDA product code for BIOACCESS MARROW HARVEST 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.

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 Bioaccess, 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.

K954151BIOACCESS BONE BIOPSY SYSTEMK953064BIOACCESS MARROW HARVEST SYSTEM

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.K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare CorpK953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.K923872BONE MARROW BIOPSY SYSTEMThe Straumann Co.

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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