Decision Date1993-01-13
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
OMNI CYSTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Expanded Optics, Inc.. It received FDA 510(k) clearance on 1993-01-13 under 510(k) number K922320. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OMNI CYSTOSCOPE?
OMNI CYSTOSCOPE is a medical device that received FDA 510(k) clearance on 1993-01-13. The listed applicant is Expanded Optics, Inc.. The 510(k) number is K922320.
When did OMNI CYSTOSCOPE receive FDA 510(k) clearance?
OMNI CYSTOSCOPE received FDA 510(k) clearance on 1993-01-13, under 510(k) number K922320.
Who is the listed applicant for OMNI CYSTOSCOPE?
The FDA 510(k) record lists Expanded Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OMNI CYSTOSCOPE?
The FDA product code for OMNI CYSTOSCOPE is FAJ.
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.
Other records listing Expanded Optics, 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.
Related Devices (Code: FAJ)
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.
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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.