| Device Type ID | 3701 |
| Device Name | Neurosurgical Paddie |
| Regulation Description | Neurosurgical Paddie. |
| 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 | 882.4700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HBA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3701 |
| Device | Neurosurgical Paddie |
| Product Code | HBA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neurosurgical Paddie. |
| CFR Regulation Number | 882.4700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Component Missing | 51 |
Incorrect Device Or Component Shipped | 30 |
Device Contamination With Chemical Or Other Material | 16 |
Detachment Of Device Or Device Component | 13 |
Device Misassembled During Manufacturing / Shipping | 10 |
Device Contaminated During Manufacture Or Shipping | 7 |
Material Frayed | 7 |
Material Discolored | 6 |
Detachment Of Device Component | 6 |
Contamination During Use | 4 |
Appropriate Term/Code Not Available | 4 |
Product Quality Problem | 3 |
Insufficient Information | 3 |
Break | 2 |
Device Or Device Fragments Location Unknown | 2 |
Device Issue | 2 |
Use Of Device Problem | 2 |
Contamination / Decontamination Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Delivered As Unsterile Product | 1 |
Defective Component | 1 |
Material Fragmentation | 1 |
Unsealed Device Packaging | 1 |
Material Separation | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
| Total Device Problems | 178 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Surgical Company | II | May-26-2016 |