Male Remeex System

FDA 510(k) K062341 · Specialities Remeex International, S.L.

Substantially Equivalent

510(k) numberK062341

Submission

Device name
Male Remeex System
Applicant
Specialities Remeex International, S.L.
Minneapolis, MN, US
Received
August 10, 2006
Decision date
November 2, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OTM – Mesh, Surgical, For Stress Urinary Incontinence, Male
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

surgical treatment of male stress urinary incontinence post-prostatectomy

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K101297Virtue Ventral Urethral Elevation Sling System Model 50020OTM · Special Coloplast A/S06/03/2010SE
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More from Cl Medical

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K063136Needleless SlingPAH · Traditional 12/19/2006SE
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Questions and answers

When was Male Remeex System cleared by the FDA?

Male Remeex System (K062341) received a 510(k) decision of Substantially Equivalent on November 2, 2006, 84 days after the submission was received.

What is the product code of K062341?

The FDA product code is OTM – Mesh, Surgical, For Stress Urinary Incontinence, Male, a Class II (moderate risk) device regulated under 21 CFR 878.3300.