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 | 1438 |
| Device Name | Bronchoscope (flexible Or 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 | EOQ |
| 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 | 1438 |
| Device | Bronchoscope (flexible Or Rigid) |
| Product Code | EOQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bronchoscope (flexible Or Rigid) And Accessories. |
| CFR Regulation Number | 874.4680 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMBU A/S | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AMBU INTERNATIONAL A/S | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
COOK ENDOSCOPY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HOYA CORPORATION PENTAX DIVISION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
INTUITIVE SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PENTAX | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PROSURG, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SANOVAS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCHOLLY FIBEROPTIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPIRATION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 205 |
Microbial Contamination Of Device | 166 |
Appropriate Term/Code Not Available | 130 |
Needle | 113 |
Break | 109 |
Bent | 88 |
Endoscope | 84 |
Device Issue | 49 |
Device Reprocessing Problem | 37 |
Loose Or Intermittent Connection | 34 |
Detachment Of Device Component | 29 |
Tip | 29 |
Contamination / Decontamination Problem | 21 |
Material Puncture / Hole | 18 |
Device Disinfection Or Sterilization Issue | 16 |
Insufficient Information | 16 |
Detachment Of Device Or Device Component | 14 |
Material Separation | 10 |
Material Fragmentation | 9 |
Device Operates Differently Than Expected | 9 |
Peeled / Delaminated | 8 |
Material Deformation | 7 |
Fracture | 7 |
Contamination During Use | 7 |
Material Split, Cut Or Torn | 7 |
Use Of Device Problem | 6 |
Balloon | 6 |
Difficult To Remove | 6 |
Failure To Sense | 6 |
Device Contamination With Biological Material | 6 |
Component Incompatible | 6 |
Device Handling Problem | 6 |
Device Contamination With Chemical Or Other Material | 5 |
Device Damaged By Another Device | 4 |
Thermal Decomposition Of Device | 4 |
Obstruction Of Flow | 4 |
Maintenance Does Not Comply To Manufacturers Recommendations | 4 |
Loss Of Or Failure To Bond | 4 |
No Display / Image | 4 |
Material Perforation | 3 |
Mechanical Problem | 3 |
Cut In Material | 2 |
Display Or Visual Feedback Problem | 2 |
Torn Material | 2 |
Component Falling | 2 |
Flaked | 2 |
Material Rupture | 2 |
Fungus In Device Environment | 2 |
Wire | 2 |
Inadequate Service | 2 |
Migration Or Expulsion Of Device | 2 |
Material Disintegration | 2 |
Fire | 2 |
Insulation | 2 |
Valve | 2 |
Material Integrity Problem | 2 |
Image Resolution Poor | 1 |
Failure To Service | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Improper Device Output | 1 |
Device Component Or Accessory | 1 |
Unintended Electrical Shock | 1 |
Burst Container Or Vessel | 1 |
Physical Resistance | 1 |
Activation Failure Including Expansion Failures | 1 |
Jaw | 1 |
Coiled | 1 |
Material Frayed | 1 |
Smoking | 1 |
Device Dislodged Or Dislocated | 1 |
Failure To Disconnect | 1 |
Difficult To Insert | 1 |
Kinked | 1 |
Entrapment Of Device | 1 |
Difficult To Advance | 1 |
Positioning Problem | 1 |
Naturally Worn | 1 |
Separation Problem | 1 |
Probe | 1 |
Charred | 1 |
Crack | 1 |
Overheating Of Device | 1 |
Difficult To Position | 1 |
Material Protrusion / Extrusion | 1 |
Sticking | 1 |
Image Display Error / Artifact | 1 |
Device Maintenance Issue | 1 |
Poor Quality Image | 1 |
Adhesive | 1 |
Physical Resistance / Sticking | 1 |
Cover | 1 |
| Total Device Problems | 1364 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Olympus Corporation Of The Americas | II | Sep-29-2018 |
| 2 | Pentax Medical Company | II | Jun-28-2016 |
| 3 | Pentax Of America Inc | II | Jun-09-2017 |
| 4 | Pentax Of America Inc | II | Dec-14-2016 |
| 5 | Pentax Of America Inc | II | Sep-22-2016 |