FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

MEDICON TITANIUM YASARGIL ANEURYSM CLIPS

K Number: K010908 · Decision Aug 1, 2001
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
35
Applicant Total
17
Review Days
128

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Basic Information

Device Name
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
K Number
K010908
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5200
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Medicon EG
Date Received
March 26, 2001
Decision Date
August 1, 2001
Product Code
HCH
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HCH Clip, Aneurysm

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Other Clearances by Medicon EG

K Number Device Name
K161680 MEDICON Spinal Spreading Systems
K100916 MEDICON MOGEN CLAMP
K083803 FIXIT HEADREST CLAMP SYSTEM
K053624 MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
K050478 MEDICON IMF-ORION SCREWS
K043297 MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
K042974 MEDICON VIPAIR HIGH SPEED SYSTEM
K041527 AARHUS ANCHORAGE SYSTEM
K010910 MEDICON YASARGIL CLIP APPLYING FORCEPS
K972857 SERVOTRONIC EC100 SYSTEM
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