I-STOP TRANS OBTURATOR MALE SLING— 510(k) K063079

Name: FDA 510(k) clearance K063079
Creator: U.S. Food and Drug Administration
Published: 2006-11-07

Substantially Equivalent

Cl Medical

FDA 510(k) clearance K063079 for I-STOP TRANS OBTURATOR MALE SLING, Substantially Equivalent on 2006-11-07. Applicant: Cl Medical. Device class: 2.

Clearance details

Applicant: Cl Medical
Product code: Code OTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2006-10-10
Decision date: 2006-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sainte Foy Les Lyon, FR

Download summary PDF View on FDA.gov ↗

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K242960 — AdVance XP Male Sling System (720163-03)2024-11-15
K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit2023-09-25
K211847 — AdVance XP Male Sling System2021-12-20
K182169 — AdVance XP Male Sling2018-11-27
K113496 — VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT2012-02-14

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K051533 — I-STOP2005-08-11

Adverse events under product code OTM

product code OTM

Injury: 760
Total: 760

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.