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FDA 510(k)

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

K-Number: K192339 · 2020-01-30

ApplicantWilson-Cook Medical, Inc.
Decision Date2020-01-30
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2020-01-30 under approval number K192339. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord?

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord is a medical device that received FDA 510(k) clearance on 2020-01-30. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K192339.

When was TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord approved by the FDA?

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord received FDA 510(k) clearance on 2020-01-30, under approval number K192339.

What company makes TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord?

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord?

The FDA product code for TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord is KNS.

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Related Devices (Code: KNS)

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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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