510(k) K211975
- Device
- Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
- Applicant
- Caldera Medical, Inc.
- 510(k) number
- K211975
- Product code
- OTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-10
- Date received
- 2021-06-25
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Vicki Gail
- Address
- 4360 Park Ter. Dr. Westlake Village CA US 91361 91361
FDA Registration Numbers#
- 1018233
- 3014272734
- 3013859837
- 9681260
- 3012159165
- 3005099803
- 3004756681
- 3018783201
- 3007156625
- 3008627763
- 3016678045
- 3004612223
- 1828132
- 1000121056
- 2529647
- 3010273872
- 3017791709
- 3006082230
- 3004838863
- 3000203391
- 3010178296
- 3006621295
- 3005636544
- 3003702646
- 2124215
- 2183744
- 2125050
- 3003990090
Source Documents#
Other 510(k) Records For Product Code OTN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2023-06-29 |
| K222293 | ArcSP Suprapubic Sling System | Urocure, LLC | 2022-09-21 |
| K222468 | ArcTO Transobturator Sling System | Urocure, LLC | 2022-09-15 |
| K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2021-07-21 |
| K210087 | Athena Surgical RMUS System | Athena Surgical, LLC | 2021-04-12 |
| K201686 | GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide | ETHICON, Inc. | 2020-09-17 |
| K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | 2019-02-07 |
| K162201 | Desara TV, Desara Blue TV | Caldera Medical, Inc. | 2017-01-11 |
| K140843 | DESARA BLUE OV, DESARA BLUE SS | Caldera Medical | 2014-07-01 |
| K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | American Medical Systems | 2013-12-05 |
| K132655 | RETROARC RETROPUBIC SLING SYSTEM | American Medical Systems, Inc. | 2013-11-20 |
| K132069 | DESARA MESH, DESARA BLUE | Caldera Medical, Inc. | 2013-09-23 |
| K132054 | GYNECARE TVT EXACT CONTINENCE SYSTEM | ETHICON, Inc. | 2013-08-23 |
| K121928 | DESARA SL | Caldera Medical, Inc. | 2013-02-19 |
| K121754 | BLUE SUI SLING | Boston Scientific Corp | 2012-10-10 |
Legacy Summary#
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FDA Review#
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