Decision Date2020-10-29
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Flexible Video Cysto-Urethroscope (C-view) is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K202957. 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 Flexible Video Cysto-Urethroscope (C-view)?
Flexible Video Cysto-Urethroscope (C-view) is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K202957.
When did Flexible Video Cysto-Urethroscope (C-view) receive FDA 510(k) clearance?
Flexible Video Cysto-Urethroscope (C-view) received FDA 510(k) clearance on 2020-10-29, under 510(k) number K202957.
Who is the listed applicant for Flexible Video Cysto-Urethroscope (C-view)?
The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Flexible Video Cysto-Urethroscope (C-view)?
The FDA product code for Flexible Video Cysto-Urethroscope (C-view) is FAJ.
Other records listing KARL STORZ Endoscopy-America, 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.
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Related Devices (Code: FAJ)
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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.