FDA 510(k)

AdVance XP Male Sling System

K-Number: K211847 · 2021-12-20

Decision Date2021-12-20

Product CodeOTM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AdVance XP Male Sling System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-12-20 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K211847.

When did AdVance XP Male Sling System receive FDA 510(k) clearance?

AdVance XP Male Sling System received FDA 510(k) clearance on 2021-12-20, under 510(k) number K211847.

Who is the listed applicant for AdVance XP Male Sling System?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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.