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FDA 510(k)

OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER

K-Number: K991377 · 1999-07-12

ApplicantOmnisonics Medical Technologies
Decision Date1999-07-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER is the device name listed in this FDA 510(k) record. The listed applicant is Omnisonics Medical Technologies. It received FDA 510(k) clearance on 1999-07-12 under 510(k) number K991377. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER?

OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER is a medical device that received FDA 510(k) clearance on 1999-07-12. The listed applicant is Omnisonics Medical Technologies. The 510(k) number is K991377.

When did OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER receive FDA 510(k) clearance?

OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER received FDA 510(k) clearance on 1999-07-12, under 510(k) number K991377.

Who is the listed applicant for OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER?

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

What is the FDA product code for OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER?

The FDA product code for OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER is GCJ.

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Other records listing Omnisonics Medical Technologies 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.

K083335MODIFIED OMNIWAVE ENDOVASCULAR SYSTEMK071762OMNIWAVE ENDOVASCULAR SYSTEMK052428RESOLUTION ENDOVASCULAR SYSTEMK041705RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2K003824OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STIK993628OMNISONICS ULTRASONIC PROBES

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Related Devices (Code: GCJ)

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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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