FDA 510(k)

MONOFIX PDO

Numéro K : K253879 · 2026-08-25

Date de décision2026-08-25

Code produitNEW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

MONOFIX PDO is the device name listed in this FDA 510(k) record. The listed applicant is Samyang Holdings Corporation. It received FDA 510(k) clearance on 2026-08-25 under 510(k) number K253879. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MONOFIX PDO?

MONOFIX PDO is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Samyang Holdings Corporation. The 510(k) number is K253879.

When did MONOFIX PDO receive FDA 510(k) clearance?

MONOFIX PDO received FDA 510(k) clearance on 2026-08-25, under 510(k) number K253879.

Who is the listed applicant for MONOFIX PDO?

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

What is the FDA product code for MONOFIX PDO?

The FDA product code for MONOFIX PDO is NEW.

Essais cliniques associés

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Dispositifs connexes (Code : NEW)

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Source officielle

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