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FDA 510(k)

DRIM-Nail System

K-Number: K260115 · 2026-09-11

Applicant41Medical AG
Decision Date2026-09-11
Product Code
DecisionSubstantially Equivalent

Device Summary

DRIM-Nail System is the device name listed in this FDA 510(k) record. The listed applicant is 41Medical AG. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K260115. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRIM-Nail System?

DRIM-Nail System is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is 41Medical AG. The 510(k) number is K260115.

When did DRIM-Nail System receive FDA 510(k) clearance?

DRIM-Nail System received FDA 510(k) clearance on 2026-09-11, under 510(k) number K260115.

Who is the listed applicant for DRIM-Nail System?

The FDA 510(k) record lists 41Medical AG as the applicant. This does not by itself establish the device manufacturer.

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.