FDA 510(k)

EXTRON 3;EXTRON 6

K-Number: K261413 · 2026-08-19

Decision Date2026-08-19

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EXTRON 3;EXTRON 6 is the device name listed in this FDA 510(k) record. The listed applicant is DRTECH Corporation. It received FDA 510(k) clearance on 2026-08-19 under 510(k) number K261413. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRON 3;EXTRON 6?

EXTRON 3;EXTRON 6 is a medical device that received FDA 510(k) clearance on 2026-08-19. The listed applicant is DRTECH Corporation. The 510(k) number is K261413.

When did EXTRON 3;EXTRON 6 receive FDA 510(k) clearance?

EXTRON 3;EXTRON 6 received FDA 510(k) clearance on 2026-08-19, under 510(k) number K261413.

Who is the listed applicant for EXTRON 3;EXTRON 6?

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

What is the FDA product code for EXTRON 3;EXTRON 6?

The FDA product code for EXTRON 3;EXTRON 6 is OWB.

Other records listing DRTECH Corporation 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.

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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.