Definition: If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 FR 26807, Available At Https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
| Device Type ID | 3639 |
| Device Name | Endoscope, Neurological |
| Regulation Description | Neurological Endoscope. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1480 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GWG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3639 |
| Device | Endoscope, Neurological |
| Product Code | GWG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neurological Endoscope. |
| CFR Regulation Number | 882.1480 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KARL STORZ GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
KARL STORZ SE & CO KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MAUNA KEA TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MRI INTERVENTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PENUMBRA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 11 |
Leak / Splash | 8 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Break | 6 |
Mechanical Problem | 5 |
Out-Of-Box Failure | 5 |
Device Operational Issue | 5 |
Complete Blockage | 4 |
Poor Quality Image | 4 |
Material Protrusion / Extrusion | 3 |
Defective Device | 3 |
Fluid Leak | 2 |
Failure To Conduct | 2 |
Device Damaged Prior To Use | 2 |
Pumping Problem | 2 |
Material Fragmentation | 2 |
Aspiration Issue | 2 |
Image Resolution Poor | 2 |
Vibration | 1 |
Defective Component | 1 |
Solder Joint Fracture | 1 |
Material Integrity Problem | 1 |
Material Disintegration | 1 |
False Positive Result | 1 |
Difficult To Remove | 1 |
Date/Time-Related Software Problem | 1 |
Balloon | 1 |
Loss Of Or Failure To Bond | 1 |
Device Difficult To Setup Or Prepare | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Arcing Of Electrodes | 1 |
Appropriate Term/Code Not Available | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Device-Device Incompatibility | 1 |
Material Deformation | 1 |
Detachment Of Device Component | 1 |
Loss Of Power | 1 |
Material Separation | 1 |
Failure To Deliver Energy | 1 |
Device Handling Problem | 1 |
Failure To Disconnect | 1 |
Decrease In Suction | 1 |
Disconnection | 1 |
Kinked | 1 |
Material Rupture | 1 |
Inadequate User Interface | 1 |
Overheating Of Device | 1 |
Display Or Visual Feedback Problem | 1 |
| Total Device Problems | 106 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap Implant Systems LLC | II | Mar-20-2017 |