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FDA 510(k)

XT3 System

K-Number: K241357 · 2025-01-22

ApplicantBiodynamik, Inc.
Decision Date2025-01-22
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XT3 System is a medical device manufactured by Biodynamik, Inc.. It received FDA 510(k) clearance on 2025-01-22 under approval number K241357. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XT3 System?

XT3 System is a medical device that received FDA 510(k) clearance on 2025-01-22. It is manufactured by Biodynamik, Inc.. The 510(k) number is K241357.

When was XT3 System approved by the FDA?

XT3 System received FDA 510(k) clearance on 2025-01-22, under approval number K241357.

What company makes XT3 System?

XT3 System is manufactured by Biodynamik, Inc..

What is the FDA product code for XT3 System?

The FDA product code for XT3 System is JDW.

Other Devices by Biodynamik, Inc.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

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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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