FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MEDICON MOGEN CLAMP
K Number: K100916
·
Decision Dec 6, 2010
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
17
Review Days
248
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MEDICON MOGEN CLAMP
- K Number
- K100916
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicon EG
- Date Received
- April 2, 2010
- Decision Date
- December 6, 2010
- Product Code
- HFX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HFX | Clamp, Circumcision | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFX), ordered by most recent decision date.
Konig Bell Circumcision Clamp
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Wee Bell
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Konig Mogen Clamp
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Circumplast Circumcision Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MALE CIRCUMCISION KITS:RAPIDECLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SHANGRING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Medicon EG
| K Number | Device Name | ||
|---|---|---|---|
| K161680 | MEDICON Spinal Spreading Systems | Mar 24, 2017 | Substantially Equivalent |
| K083803 | FIXIT HEADREST CLAMP SYSTEM | Mar 10, 2010 | Substantially Equivalent |
| K053624 | MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM | Jul 17, 2006 | Substantially Equivalent |
| K050478 | MEDICON IMF-ORION SCREWS | Jun 15, 2005 | Substantially Equivalent |
| K043297 | MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM | Feb 23, 2005 | Substantially Equivalent |
| K042974 | MEDICON VIPAIR HIGH SPEED SYSTEM | Jan 13, 2005 | Substantially Equivalent |
| K041527 | AARHUS ANCHORAGE SYSTEM | Aug 19, 2004 | Substantially Equivalent |
| K010910 | MEDICON YASARGIL CLIP APPLYING FORCEPS | Aug 1, 2001 | Substantially Equivalent |
| K010908 | MEDICON TITANIUM YASARGIL ANEURYSM CLIPS | Aug 1, 2001 | Substantially Equivalent |
| K972857 | SERVOTRONIC EC100 SYSTEM | Jan 16, 1998 | Substantially Equivalent |