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FDA 510(k)

SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM

K-Number: K943593 · 1995-03-22

ApplicantOvamed Corp.
Decision Date1995-03-22
Product CodeODF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ovamed Corp.. It received FDA 510(k) clearance on 1995-03-22 under 510(k) number K943593. The device is classified under product code ODF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM?

SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is Ovamed Corp.. The 510(k) number is K943593.

When did SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM receive FDA 510(k) clearance?

SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM received FDA 510(k) clearance on 1995-03-22, under 510(k) number K943593.

Who is the listed applicant for SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM?

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

What is the FDA product code for SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM?

The FDA product code for SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM is ODF.

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 Ovamed Corp. 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.

K951946HYSTEROSYS FLEXIBLE HYSTEROCOPEK931534OVAMED INTRAUTERINE ACCESS CATHETERK931167OVAMED FALLOPIAN OSTIAL ACCESS CATHETERK931122OVAMED HSG CATHETER

Related Devices (Code: ODF)

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.

K092739MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILEC-Link Micro Imaging, Inc.K091962POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200Lumenis, Inc.K090170SPYSCOPE ACCESS AND DELIVERY CATHETERBoston Scientific CorpK052194SPYGLASS DIRECT VISUALIZATION PROBE AND OCULARBoston Scientific CorpK050403SPYGLASS DIRECT VISULATION PROBEBoston Scientific CorpK9633545 STAR MEDICAL ENDOSCOPEFive Star Medical, Inc.

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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