Decision Date2019-01-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Flex-THOR scope 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 2019-01-18 under 510(k) number K183264. 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 Flex-THOR scope?
Flex-THOR scope is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K183264.
When did Flex-THOR scope receive FDA 510(k) clearance?
Flex-THOR scope received FDA 510(k) clearance on 2019-01-18, under 510(k) number K183264.
Who is the listed applicant for Flex-THOR scope?
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 Flex-THOR scope?
The FDA product code for Flex-THOR scope is GCJ.
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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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.