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FDA 510(k)

TauTona Pneumoperitoneum Assist Device (TPAD)

K-Number: K233020 · 2024-01-12

ApplicantTautona Group Research & Development, Co., LLC
Decision Date2024-01-12
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Tautona Group Research & Development, Co., LLC. The 510(k) number is K233020.

When was TauTona Pneumoperitoneum Assist Device (TPAD) approved by the FDA?

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

What company makes TauTona Pneumoperitoneum Assist Device (TPAD)?

TauTona Pneumoperitoneum Assist Device (TPAD) is manufactured by Tautona Group Research & Development, Co., LLC.

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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Related PubMed Literature

PMID: 40060767 Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation. Bioengineering & translational medicine (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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