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 | 1590 |
| Device Name | Bronchoscope Accessory |
| 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 | KTI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1590 |
| Device | Bronchoscope Accessory |
| Product Code | KTI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bronchoscope (flexible Or Rigid) And Accessories. |
| CFR Regulation Number | 874.4680 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTUIT MEDICAL PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIVATORS REPROCESSING SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIVATORS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SPIRATION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Balloon | 9 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Deflation Problem | 4 |
Leak / Splash | 4 |
Break | 4 |
Needle | 3 |
Insufficient Information | 3 |
Burst Container Or Vessel | 3 |
Material Puncture / Hole | 2 |
Material Deformation | 2 |
Detachment Of Device Component | 1 |
Hole In Material | 1 |
Material Separation | 1 |
Cut In Material | 1 |
Inadequate User Interface | 1 |
Torn Material | 1 |
Disconnection | 1 |
Device Markings / Labelling Problem | 1 |
Retraction Problem | 1 |
Failure To Unwrap | 1 |
Material Disintegration | 1 |
Bent | 1 |
Valve | 1 |
| Total Device Problems | 51 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Richard Wolf GmbH | II | Feb-06-2019 |