Align and Align to Urethral Support Systems
FDA 510(k) K093747 · C.R. Bard, Inc.
510(k) numberK093747
Submission
- Device name
- Align and Align to Urethral Support Systems
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- December 4, 2009
- Decision date
- May 7, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
Other 510(k)s with product code OTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Special | Boston Scientific Corporation | 06/29/2023SE |
| K222293 | ArcSP Suprapubic Sling SystemOTN · Special | Urocure, LLC | 09/21/2022SE |
| K222468 | ArcTO Transobturator Sling SystemOTN · Special | Urocure, LLC | 09/15/2022SE |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara…OTN · Special | Caldera Medical, Inc. | 11/10/2021SE |
| K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Traditional | Boston Scientific Corporation | 07/21/2021SE |
| K210087 | Athena Surgical RMUS SystemOTN · Traditional | Athena Surgical, LLC | 04/12/2021SE |
| K201686 | GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT…OTN · Traditional | ETHICON, Inc. | 09/17/2020SE |
| K183134 | ArcTV Transvaginal Sling SystemOTN · Traditional | Urocure, LLC | 02/07/2019SE |
| K162201 | Desara TV, Desara Blue TVOTN · Traditional | Caldera Medical, Inc. | 01/11/2017SE |
| K140843 | Desara Blue Ov, Desara Blue SSOTN · Special | Caldera Medical | 07/01/2014SE |
More from Caldera Medical
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Align and Align to Urethral Support Systems cleared by the FDA?
Align and Align to Urethral Support Systems (K093747) received a 510(k) decision of Substantially Equivalent on May 7, 2010, 154 days after the submission was received.
What is the product code of K093747?
The FDA product code is OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.