AdVance XP Male Sling System— 510(k) K211847
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K211847 for AdVance XP Male Sling System, Substantially Equivalent on 2021-12-20. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code OTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marborough, MA, US
Recent devices under product code OTM
view all- K242960 — AdVance XP Male Sling System (720163-03)
- K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
- K182169 — AdVance XP Male Sling
- K113496 — VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
- K111881 — VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
More clearances from Boston Scientific Corporation
view allAdverse events under product code OTM
product code OTM- Injury
- 760
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.