AdVance XP Male Sling System
K-Number: K211847 · 2021-12-20
ApplicantBoston Scientific Corporation
Decision Date2021-12-20
Product CodeOTM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AdVance XP Male Sling System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-12-20 under approval number K211847. The device is classified under product code OTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AdVance XP Male Sling System?
AdVance XP Male Sling System is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by Boston Scientific Corporation. The 510(k) number is K211847.
When was AdVance XP Male Sling System approved by the FDA?
AdVance XP Male Sling System received FDA 510(k) clearance on 2021-12-20, under approval number K211847.
What company makes AdVance XP Male Sling System?
AdVance XP Male Sling System is manufactured by Boston Scientific Corporation.
What is the FDA product code for AdVance XP Male Sling System?
The FDA product code for AdVance XP Male Sling System is OTM.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.