Device Type ID | 5763 |
Device Name | Marker, Radiographic, Implantable |
Regulation Description | Implantable Clip. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
Submission Type | 510(k) |
CFR Regulation Number | 878.4300 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NEU |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5763 |
Device | Marker, Radiographic, Implantable |
Product Code | NEU |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Implantable Clip. |
CFR Regulation Number | 878.4300 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
AUGMENIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BREAST-MED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C. R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CIANNA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK ENDOSCOPY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DEVICOR MEDICAL PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FOCAL THERAPEUTICS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HEALTH BEACONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCION MEDICAL TECHNOLOGIES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOMATEX MEDICAL TECHNOLOGIES GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VISCUS BIOLOGICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Device Problems | |
---|---|
Device Damaged By Another Device | 74 |
Adverse Event Without Identified Device Or Use Problem | 40 |
Bent | 35 |
Migration Or Expulsion Of Device | 19 |
Positioning Failure | 19 |
Needle | 19 |
Detachment Of Device Or Device Component | 16 |
Patient-Device Incompatibility | 16 |
Break | 13 |
Material Fragmentation | 13 |
Signal Artifact | 9 |
Difficult To Remove | 7 |
Retraction Problem | 5 |
Use Of Device Problem | 5 |
Poor Quality Image | 5 |
Device Contamination With Chemical Or Other Material | 5 |
Separation Failure | 4 |
Nonstandard Device | 4 |
Insufficient Information | 4 |
Activation, Positioning Or Separation Problem | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Device Operates Differently Than Expected | 3 |
Material Twisted / Bent | 2 |
Migration | 2 |
Difficult To Insert | 2 |
Kinked | 2 |
Material Separation | 2 |
Patient Device Interaction Problem | 1 |
Incorrect Device Or Component Shipped | 1 |
Material Deformation | 1 |
Device Markings / Labelling Problem | 1 |
Cut In Material | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Failure To Advance | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Appropriate Term/Code Not Available | 1 |
Material Split, Cut Or Torn | 1 |
Failure To Eject | 1 |
Difficult Or Delayed Positioning | 1 |
Total Device Problems | 345 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Somatex Medical Technologies GmbH | II | Jan-24-2018 |