AdVance XP Male Sling System
FDA 510(k) K211847 · Boston Scientific Corporation
510(k) numberK211847
Submission
- Device name
- AdVance XP Male Sling System
- Applicant
- Boston Scientific Corporation
Marborough, MA, US - Received
- June 15, 2021
- Decision date
- December 20, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OTM – Mesh, Surgical, For Stress Urinary Incontinence, Male
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
surgical treatment of male stress urinary incontinence post-prostatectomy
Other 510(k)s with product code OTM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242960 | AdVance XP Male Sling System (720163-03)OTM · Traditional | Boston Scientific Corporation | 11/15/2024SE |
| K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience KitOTM · Traditional | Coloplast | 09/25/2023SESK |
| K182169 | AdVance XP Male SlingOTM · Traditional | Boston Scientific Corporation | 11/27/2018SE |
| K113496 | Virture Male Sling System with Alexis Wound Retractor Convenience KitOTM · Traditional | Coloplast A/S | 02/14/2012SE |
| K111881 | Virtue Male Sling System and Alexis(R) Wound Retractor KitOTM · Traditional | Coloplast A/S | 08/17/2011SE |
| K101297 | Virtue Ventral Urethral Elevation Sling System Model 50020OTM · Special | Coloplast A/S | 06/03/2010SE |
| K091152 | Virtue Ventral Urethral Elevation Sling System, Model 50020OTM · Special | Coloplast A/S | 05/07/2009SE |
| K082640 | Virtue Ventral Urethral Elevation Sling SystemOTM · Traditional | Coloplast Manufacturing Us, LLC | 10/17/2008SE |
| K063079 | I-Stop Trans Obturator Male SlingOTM · Traditional | Cl Medical | 11/07/2006SE |
| K062341 | Male Remeex SystemOTM · Traditional | Specialities Remeex International, S.L. | 11/02/2006SE |
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Questions and answers
When was AdVance XP Male Sling System cleared by the FDA?
AdVance XP Male Sling System (K211847) received a 510(k) decision of Substantially Equivalent on December 20, 2021, 188 days after the submission was received.
What is the product code of K211847?
The FDA product code is OTM – Mesh, Surgical, For Stress Urinary Incontinence, Male, a Class II (moderate risk) device regulated under 21 CFR 878.3300.