Class Class II
TauTona Pneumoperitoneum Assist Device (TPAD) (K242536)
Description
TauTona Pneumoperitoneum Assist Device (TPAD) by Tautona Group, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242536
Clearance Date2024-10-15
Clearance TypeTraditional
Product CodeHIF
Regulation Number884.1730
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242536
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TauTona Pneumoperitoneum Assist Device (TPAD) (K242536) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Developmen... | 2024 |
Trace the full predicate network for K242536
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.