AdVance XP Male Sling
K-Number: K182169 · 2018-11-27
ApplicantBoston Scientific Corporation
Decision Date2018-11-27
Product CodeOTM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AdVance XP Male Sling is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-11-27 under approval number K182169. 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?
AdVance XP Male Sling is a medical device that received FDA 510(k) clearance on 2018-11-27. It is manufactured by Boston Scientific Corporation. The 510(k) number is K182169.
When was AdVance XP Male Sling approved by the FDA?
AdVance XP Male Sling received FDA 510(k) clearance on 2018-11-27, under approval number K182169.
What company makes AdVance XP Male Sling?
AdVance XP Male Sling is manufactured by Boston Scientific Corporation.
What is the FDA product code for AdVance XP Male Sling?
The FDA product code for AdVance XP Male Sling 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.