TauTona Pneumoperitoneum Assist Device (TPAD)
FDA 510(k) clearance K233020 · decided 2024-01-12
Clearance details
- K-number
- K233020
- Device name
- TauTona Pneumoperitoneum Assist Device (TPAD)
- Applicant
- Tautona Group Research & Development, Co., LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-09-22
- Decision date
- 2024-01-12
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.