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FDA 510(k)

Sentient Manufacturing Laser Fiber

Número K: K213554 · 2022-02-02

RequerenteSentient Manufacturing , LLC
Data da decisão2022-02-02
Código do produtoGEX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sentient Manufacturing Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Sentient Manufacturing , LLC. It received FDA 510(k) clearance on 2022-02-02 under 510(k) number K213554. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sentient Manufacturing Laser Fiber?

Sentient Manufacturing Laser Fiber is a medical device that received FDA 510(k) clearance on 2022-02-02. The listed applicant is Sentient Manufacturing , LLC. The 510(k) number is K213554.

When did Sentient Manufacturing Laser Fiber receive FDA 510(k) clearance?

Sentient Manufacturing Laser Fiber received FDA 510(k) clearance on 2022-02-02, under 510(k) number K213554.

Who is the listed applicant for Sentient Manufacturing Laser Fiber?

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

What is the FDA product code for Sentient Manufacturing Laser Fiber?

The FDA product code for Sentient Manufacturing Laser Fiber is GEX. This falls under the Gastroenterology category.

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