FDA 510(k)

Valence InVent Xtend™ (CVG-4101-VXA)

K-Number: K253807 · 2026-08-20

ApplicantConvergence Medical Sciences , Ltd.

Decision Date2026-08-20

Product CodeMOD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Valence InVent Xtend™ (CVG-4101-VXA) is the device name listed in this FDA 510(k) record. The listed applicant is Convergence Medical Sciences , Ltd.. It received FDA 510(k) clearance on 2026-08-20 under 510(k) number K253807. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Valence InVent Xtend™ (CVG-4101-VXA)?

Valence InVent Xtend™ (CVG-4101-VXA) is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Convergence Medical Sciences , Ltd.. The 510(k) number is K253807.

When did Valence InVent Xtend™ (CVG-4101-VXA) receive FDA 510(k) clearance?

Valence InVent Xtend™ (CVG-4101-VXA) received FDA 510(k) clearance on 2026-08-20, under 510(k) number K253807.

Who is the listed applicant for Valence InVent Xtend™ (CVG-4101-VXA)?

The FDA 510(k) record lists Convergence Medical Sciences , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Valence InVent Xtend™ (CVG-4101-VXA)?

The FDA product code for Valence InVent Xtend™ (CVG-4101-VXA) is MOD.

Related Devices (Code: MOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261360EasyCare Tx 2Resmed Corp K260051CorVision® (91-205-Z0014)CorVent® Medical, Inc.K242485EveryWareBreas Medical AB K161411Care Cycle Connect ApplicationRespironics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.