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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-11-27 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K182169.

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

AdVance XP Male Sling received FDA 510(k) clearance on 2018-11-27, under 510(k) number K182169.

Who is the listed applicant for AdVance XP Male Sling?

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?

The FDA product code for AdVance XP Male Sling is OTM.

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Related Devices (Code: OTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific CorporationK231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplastK211847AdVance XP Male Sling SystemBoston Scientific Corporation

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.

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