Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)— 510(k) K242473

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K242473 for Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562), Substantially Equivalent on 2024-10-18. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code PAH
Advisory panel: General, Plastic Surgery
Date received: 2024-08-20
Decision date: 2024-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PAH

product code PAH

Injury: 886
Malfunction: 529
Total: 1,415

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.