FDA 510(k)

AdVance™ XP Male Sling System (720163-03)

K-Number: K242960 · 2024-11-15

Decision Date2024-11-15

Product CodeOTM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AdVance™ XP Male Sling System (720163-03) 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 2024-11-15 under 510(k) number K242960. 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 (720163-03)?

AdVance™ XP Male Sling System (720163-03) is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Boston Scientific Corporation. The 510(k) number is K242960.

When did AdVance™ XP Male Sling System (720163-03) receive FDA 510(k) clearance?

AdVance™ XP Male Sling System (720163-03) received FDA 510(k) clearance on 2024-11-15, under 510(k) number K242960.

Who is the listed applicant for AdVance™ XP Male Sling System (720163-03)?

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 (720163-03)?

The FDA product code for AdVance™ XP Male Sling System (720163-03) 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.