TIPI OTC
FDA 510(k) clearance K131198 · decided 2013-08-27
Clearance details
- K-number
- K131198
- Device name
- TIPI OTC
- Applicant
- Contipi , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-26
- Decision date
- 2013-08-27
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- HHW
- Device class
- 2
- Regulation number
- 884.3575
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| Uresta® (K233548) | Resilia, Inc. | 2024-04-03 |
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| ProVate Vaginal Support (K190277) | Contipi Medical , Ltd. | 2019-07-08 |
| Revive Reusable Bladder Support (K183468) | Rinovum Subsidiary 2, LLC | 2019-01-25 |
| Panpac Flexi Shelf Pessary (K173351) | Panpac Medical Corporation | 2018-10-31 |
| Panpac Disposable Pessary Fitting Set (K153422) | Panpac Medical Corporation | 2016-07-14 |
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Recalls involving this device
No recalls on record reference this clearance.