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 | 1476 |
| Device Name | Mediastinoscope, Surgical |
| Regulation Description | Mediastinoscope And Accessories. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.4720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EWY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1476 |
| Device | Mediastinoscope, Surgical |
| Product Code | EWY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Mediastinoscope And Accessories. |
| CFR Regulation Number | 874.4720 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AEGIS SURGICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 8 |
Tip | 1 |
Image Resolution Poor | 1 |
Detachment Of Device Component | 1 |
| Total Device Problems | 11 |