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FDA 510(k)

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)

Número K: K233653 · 2024-08-05

RequerentePeregrine Surgical, LLC
Data da decisão2024-08-05
Código do produtoMPA
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) is the device name listed in this FDA 510(k) record. The listed applicant is Peregrine Surgical, LLC. It received FDA 510(k) clearance on 2024-08-05 under 510(k) number K233653. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)?

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) is a medical device that received FDA 510(k) clearance on 2024-08-05. The listed applicant is Peregrine Surgical, LLC. The 510(k) number is K233653.

When did Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) receive FDA 510(k) clearance?

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) received FDA 510(k) clearance on 2024-08-05, under 510(k) number K233653.

Who is the listed applicant for Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)?

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

What is the FDA product code for Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)?

The FDA product code for Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) is MPA.

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Fonte oficial

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