FDA 510(k)

Flex-THOR scope

K-Number: K183264 · 2019-01-18

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date2019-01-18

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Flex-THOR scope is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2019-01-18 under approval 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. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K183264.

When was Flex-THOR scope approved by the FDA?

Flex-THOR scope received FDA 510(k) clearance on 2019-01-18, under approval number K183264.

What company makes Flex-THOR scope?

Flex-THOR scope is manufactured by KARL STORZ Endoscopy-America, Inc..

What is the FDA product code for Flex-THOR scope?

The FDA product code for Flex-THOR scope is GCJ.

Other Devices by KARL STORZ Endoscopy-America, Inc.

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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.