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 | 1432 |
| Device Name | Brush, Biopsy, Bronchoscope (non-rigid) |
| Regulation Description | Bronchoscope (flexible Or Rigid) 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 | 874.4680 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BTG |
| 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 | 1432 |
| Device | Brush, Biopsy, Bronchoscope (non-rigid) |
| Product Code | BTG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bronchoscope (flexible Or Rigid) And Accessories. |
| CFR Regulation Number | 874.4680 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 8 |
Break | 6 |
Wire | 5 |
Catheter | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Brush | 3 |
Material Split, Cut Or Torn | 2 |
Bent | 2 |
Difficult To Remove | 1 |
Mechanical Problem | 1 |
| Total Device Problems | 37 |