Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
FDA 510(k) K211223 · Boston Scientific Corporation
510(k) numberK211223
Submission
- Device name
- Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- Applicant
- Boston Scientific Corporation
Marborough, MA, US - Received
- April 23, 2021
- Decision date
- July 21, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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 |
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| 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 |
| K131229 | Sparc System and Monarc, Monarc, and Monarc C SystemsOTN · Special | American Medical Systems | 12/05/2013SE |
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Questions and answers
When was Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System cleared by the FDA?
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (K211223) received a 510(k) decision of Substantially Equivalent on July 21, 2021, 89 days after the submission was received.
What is the product code of K211223?
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.