MINIARC PRO SINGLE-INCISION SLING SYSTEM— 510(k) K121641

Name: FDA 510(k) clearance K121641
Creator: U.S. Food and Drug Administration
Published: 2012-09-07

Substantially Equivalent

American Medical Systems

FDA 510(k) clearance K121641 for MINIARC PRO SINGLE-INCISION SLING SYSTEM, Substantially Equivalent on 2012-09-07. Applicant: American Medical Systems. Device class: 2.

Clearance details

Applicant: American Medical Systems
Product code: Code PAH
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2012-06-04
Decision date: 2012-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION2012-07-20
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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 →

Recalls naming K121641

K-number listed on FDA's recall record

Z-0279-2016 — MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.Class II·Terminated·Astora·20151026

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121641.

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