FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MALE REMEEX SYSTEM
K Number: K062341
·
Decision Nov 2, 2006
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
11
Applicant Total
3
Review Days
84
Basic Information
- Device Name
- MALE REMEEX SYSTEM
- K Number
- K062341
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SPECIALITIES REMEEX INTERNATIONAL, S.L.
- Date Received
- August 10, 2006
- Decision Date
- November 2, 2006
- Product Code
- OTM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OTM | Mesh, Surgical, For Stress Urinary Incontinence, Male | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OTM), ordered by most recent decision date.
AdVance XP Male Sling System (720163-03)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AdVance XP Male Sling System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AdVance XP Male Sling
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery