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FDA 510(k)

Tenex 2nd Generation System

K-Number: K241700 · 2024-11-18

ApplicantTrice Medical, Inc.
Decision Date2024-11-18
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Tenex 2nd Generation System is a medical device manufactured by Trice Medical, Inc.. It received FDA 510(k) clearance on 2024-11-18 under approval number K241700. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tenex 2nd Generation System?

Tenex 2nd Generation System is a medical device that received FDA 510(k) clearance on 2024-11-18. It is manufactured by Trice Medical, Inc.. The 510(k) number is K241700.

When was Tenex 2nd Generation System approved by the FDA?

Tenex 2nd Generation System received FDA 510(k) clearance on 2024-11-18, under approval number K241700.

What company makes Tenex 2nd Generation System?

Tenex 2nd Generation System is manufactured by Trice Medical, Inc..

What is the FDA product code for Tenex 2nd Generation System?

The FDA product code for Tenex 2nd Generation System is LFL.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT07593625 Evaluating Glucose Control Using a Next-Generation AID Algorithm in Adults With T1D NOT_YET_RECRUITING NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING NCT05110183 Opto-electrical Cochlear Implants ENROLLING_BY_INVITATION NCT05867927 GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications RECRUITING NCT05498376 The Leadless AV Versus DDD Pacing Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025)

Other Devices by Trice Medical, Inc.

K212556mi-eye 3 needlescope with cannula, mi-tablet 3

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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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