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FDA 510(k)

Dexter L6 System

K-Number: K260653 · 2026-06-11

ApplicantDistalmotion SA
Decision Date2026-06-11
Product CodeSDD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dexter L6 System is the device name listed in this FDA 510(k) record. The listed applicant is Distalmotion SA. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K260653. The device is classified under product code SDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dexter L6 System?

Dexter L6 System is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Distalmotion SA. The 510(k) number is K260653.

When did Dexter L6 System receive FDA 510(k) clearance?

Dexter L6 System received FDA 510(k) clearance on 2026-06-11, under 510(k) number K260653.

Who is the listed applicant for Dexter L6 System?

The FDA 510(k) record lists Distalmotion SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dexter L6 System?

The FDA product code for Dexter L6 System is SDD.

Related Clinical Trials

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.

NCT07181876Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic SystemRECRUITINGNCT07746531Robotic Minimally Invasive Benign Hysterectomy Post-market Clinical Study With the DEXTER Robotic SystemNOT_YET_RECRUITING

Other records listing Distalmotion SA as applicant

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.

K251197Dexter L6 SystemK250435Dexter L6 System

Related Devices (Code: SDD)

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.

K251197Dexter L6 SystemDistalmotion SAK250435Dexter L6 SystemDistalmotion SA

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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