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FDA 510(k)

MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE

K-Number: K092739 · 2010-01-12

ApplicantC-Link Micro Imaging, Inc.
Decision Date2010-01-12
Product CodeODF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE is the device name listed in this FDA 510(k) record. The listed applicant is C-Link Micro Imaging, Inc.. It received FDA 510(k) clearance on 2010-01-12 under 510(k) number K092739. 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 MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE?

MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE is a medical device that received FDA 510(k) clearance on 2010-01-12. The listed applicant is C-Link Micro Imaging, Inc.. The 510(k) number is K092739.

When did MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE receive FDA 510(k) clearance?

MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE received FDA 510(k) clearance on 2010-01-12, under 510(k) number K092739.

Who is the listed applicant for MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE?

The FDA 510(k) record lists C-Link Micro Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE?

The FDA product code for MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE is ODF.

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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.

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.K943593SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEMOvamed Corp.

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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