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FDA 510(k)

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

K-Number: K243568 · 2025-01-17

ApplicantWilson-Cook Medical, Inc.
Decision Date2025-01-17
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2025-01-17 under approval number K243568. 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 BiCord Active Cord?

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K243568.

When was Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord approved by the FDA?

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord received FDA 510(k) clearance on 2025-01-17, under approval number K243568.

What company makes Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord?

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord?

The FDA product code for Teslatome Bipolar Sphincterotome; Tesla BiCord 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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