Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
FDA 510(k) K231549 · Boston Scientific Corporation
510(k) numberK231549
Submission
- Device name
- Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- May 30, 2023
- Decision date
- June 29, 2023
- 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
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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 (K231549) received a 510(k) decision of Substantially Equivalent on June 29, 2023, 30 days after the submission was received.
What is the product code of K231549?
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.