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FDA 510(k)

BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)

K-Number: K970110 · 1997-02-19

ApplicantBard Medical Div.
Decision Date1997-02-19
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) is the device name listed in this FDA 510(k) record. The listed applicant is Bard Medical Div.. It received FDA 510(k) clearance on 1997-02-19 under 510(k) number K970110. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)?

BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) is a medical device that received FDA 510(k) clearance on 1997-02-19. The listed applicant is Bard Medical Div.. The 510(k) number is K970110.

When did BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) receive FDA 510(k) clearance?

BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) received FDA 510(k) clearance on 1997-02-19, under 510(k) number K970110.

Who is the listed applicant for BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)?

The FDA 510(k) record lists Bard Medical Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)?

The FDA product code for BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) is ODC.

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 Bard Medical Div. 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.

K984136BARDEX LUBRI-SIL I.C. FOLEY CATHETERK984084BARDEX LUBRI-SIL FOLEY CATHETER

Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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