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FDA 510(k)

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

Número K: K253580 · 2026-04-26

RequerenteTedan Surgical Innovations
Data da decisão2026-04-26
Código do produtoPDQ
Comité consultivoEN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) is the device name listed in this FDA 510(k) record. The listed applicant is Tedan Surgical Innovations. It received FDA 510(k) clearance on 2026-04-26 under 510(k) number K253580. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)?

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) is a medical device that received FDA 510(k) clearance on 2026-04-26. The listed applicant is Tedan Surgical Innovations. The 510(k) number is K253580.

When did Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) receive FDA 510(k) clearance?

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) received FDA 510(k) clearance on 2026-04-26, under 510(k) number K253580.

Who is the listed applicant for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)?

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

What is the FDA product code for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)?

The FDA product code for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) is PDQ.

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