K233020
- 510(k) number
- K233020
- Device name
- TauTona Pneumoperitoneum Assist Device (TPAD)
- Applicant
- Tautona Group Research & Development, Co., LLC CA · US
- Product code
- HIF — Insufflator, Laparoscopic
- Decision date
- 2024-01-12
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233020.pdf
Official FDA record: K233020
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.