FDA 510(k)

TauTona Pneumoperitoneum Assist Device (TPAD)

Número K: K233020 · 2024-01-12

RequerenteTautona Group Research & Development, Co., LLC

Data da decisão2024-01-12

Código do produtoHIF

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

TauTona Pneumoperitoneum Assist Device (TPAD) is the device name listed in this FDA 510(k) record. The listed applicant is Tautona Group Research & Development, Co., LLC. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233020. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TauTona Pneumoperitoneum Assist Device (TPAD)?

TauTona Pneumoperitoneum Assist Device (TPAD) is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Tautona Group Research & Development, Co., LLC. The 510(k) number is K233020.

When did TauTona Pneumoperitoneum Assist Device (TPAD) receive FDA 510(k) clearance?

TauTona Pneumoperitoneum Assist Device (TPAD) received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233020.

Who is the listed applicant for TauTona Pneumoperitoneum Assist Device (TPAD)?

The FDA 510(k) record lists Tautona Group Research & Development, Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TauTona Pneumoperitoneum Assist Device (TPAD)?

The FDA product code for TauTona Pneumoperitoneum Assist Device (TPAD) is HIF.

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