K233020 is an FDA 510(k) clearance for the TauTona Pneumoperitoneum Assist Device (TPAD), a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Tautona Group Research & Development, Co., LLC (Redwood City, US). The FDA issued a Cleared decision on January 12, 2024, 112 days after receiving the submission on September 22, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K233020 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 22, 2023 |
| Decision Date | January 12, 2024 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1730 |