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FDA 510(k)

TauTona Pneumoperitoneum Assist Device (TPAD)

K-Number: K242536 · 2024-10-15

ApplicantTautona Group
Decision Date2024-10-15
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TauTona Pneumoperitoneum Assist Device (TPAD) is a medical device manufactured by Tautona Group. It received FDA 510(k) clearance on 2024-10-15 under approval number K242536. 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 2024-10-15. It is manufactured by Tautona Group. The 510(k) number is K242536.

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

TauTona Pneumoperitoneum Assist Device (TPAD) received FDA 510(k) clearance on 2024-10-15, under approval number K242536.

What company makes TauTona Pneumoperitoneum Assist Device (TPAD)?

TauTona Pneumoperitoneum Assist Device (TPAD) is manufactured by Tautona Group.

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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