Product code PWJ
- Device name
- Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4910
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | ETHICON, Inc. | 2018-08-10 |
| K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | ETHICON, Inc. | 2018-07-06 |
| K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | ETHICON, Inc. | 2018-06-28 |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Ri... | Caldera Medical, Inc. | 2018-05-04 |
| K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | Boston Scientific Corporation | 2017-12-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00890594000124 | Desara Blue TVez 3.0 | Caldera Medical, Inc. | 2022-08-03 |
| 00890594000131 | Desara TVez 2.7 | Caldera Medical, Inc. | 2022-08-03 |
| 00890594000155 | Desara TVez 3.0 | Caldera Medical, Inc. | 2022-08-03 |
| 00890594000193 | Desara Blue TVez 2.7 | Caldera Medical, Inc. | 2022-08-03 |
| 00857492008003 | Transobturator Helical, Left Introducer | Caldera Medical, Inc. | 2022-08-03 |
| 00857492008010 | Transobturator Helical, Right Introducer | Caldera Medical, Inc. | 2022-08-03 |
| 00890594000094 | Desara Blue TVez 2.7 | Caldera Medical, Inc. | 2021-11-15 |
| 00890594000100 | Desara TVez 2.7 | Caldera Medical, Inc. | 2021-11-15 |
| 00890594000117 | Desara TVez 3.0 | Caldera Medical, Inc. | 2021-11-15 |
| 00890594000087 | Desara Blue TVez 3.0 | Caldera Medical, Inc. | 2021-11-15 |
| 00890594000957 | Desara One | Caldera Medical, Inc. | 2020-02-25 |
| 00890594000971 | Desara One | Caldera Medical, Inc. | 2020-02-25 |
| 00890594000933 | Transobturator Inside-Out, Right 3.2 mm Introducer | Caldera Medical, Inc. | 2019-11-05 |
| 00890594000940 | Transobturator Inside-Out, Left 3.2 mm Introducer | Caldera Medical, Inc. | 2019-11-05 |
| 00890594000018 | Transobturator Helical, Left Introducer | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000148 | Transobturator Helical, Right Introducer | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000162 | Transobturator Large Helical, Left Introducer | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000179 | Transobturator Large Helical, Right Introducer | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000186 | Transobturator Inside-Out, Left Introducer | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000209 | Transobturator Inside-Out, Right Introducer | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000216 | Transobturator Hook Introducer | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000223 | Suprapubic Introducer | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000230 | Transvaginal 4.0 mm Introducer | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000278 | Winged Guide Accessory | Caldera Medical, Inc. | 2019-09-30 |
| 00890594000865 | Transvaginal 3.2 mm Introducer | Caldera Medical, Inc. | 2019-09-30 |