MALE REMEEX SYSTEM— 510(k) K062341

Name: FDA 510(k) clearance K062341
Creator: U.S. Food and Drug Administration
Published: 2006-11-02

Substantially Equivalent

Specialities Remeex International, S.L.

FDA 510(k) clearance K062341 for MALE REMEEX SYSTEM, Substantially Equivalent on 2006-11-02. Applicant: Specialities Remeex International, S.L.. Device class: 2.

Clearance details

Applicant: Specialities Remeex International, S.L.
Product code: Code OTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2006-08-10
Decision date: 2006-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Specialities Remeex International, S.L.

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K063136 — NEEDLELESS SLING2006-12-19
K033310 — REMEEX SYSTEM FOR URINARY INCONTINENCE2004-01-15

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.