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 | 1437 |
| Device Name | Nasopharyngoscope (flexible Or Rigid) |
| Regulation Description | Nasopharyngoscope (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 | 874.4760 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EOB |
| 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 | 1437 |
| Device | Nasopharyngoscope (flexible Or Rigid) |
| Product Code | EOB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nasopharyngoscope (flexible Or Rigid) And Accessories. |
| CFR Regulation Number | 874.4760 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCLARENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AMBU A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AMBU INTERNATIONAL A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ECLERIS USA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GYRUS ACMI, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOYA CORPORATION PENTAX DIVISION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KARL STORZ GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KARL STORZ SE & CO KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDROBOTICS CORP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC XOMED INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PENTAX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SATELEC-ACTEON GROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCHOELLY FIBEROPTIC, GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCHOLLY FIBEROPTIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
No Display / Image | 31 |
Break | 17 |
Adverse Event Without Identified Device Or Use Problem | 16 |
Endoscope | 11 |
Erratic Or Intermittent Display | 11 |
Microbial Contamination Of Device | 10 |
Material Fragmentation | 7 |
Fracture | 7 |
Display Or Visual Feedback Problem | 6 |
Valve | 5 |
Device Operates Differently Than Expected | 4 |
Contamination / Decontamination Problem | 4 |
Communication Or Transmission Problem | 3 |
Power Problem | 3 |
Loose Or Intermittent Connection | 3 |
Material Deformation | 3 |
Detachment Of Device Component | 2 |
Image Display Error / Artifact | 2 |
Poor Quality Image | 2 |
Device Disinfection Or Sterilization Issue | 2 |
Output Problem | 2 |
Overheating Of Device | 2 |
Insufficient Information | 2 |
Issue With Displayed Error Message | 2 |
Device Reprocessing Problem | 2 |
Wrinkled | 2 |
Device Displays Incorrect Message | 2 |
Jaw | 1 |
Loss Of Or Failure To Bond | 1 |
Use Of Device Problem | 1 |
Difficult To Open Or Close | 1 |
Display Difficult To Read | 1 |
Failure To Read Input Signal | 1 |
Device Inoperable | 1 |
Battery Problem | 1 |
Charging Problem | 1 |
Improper Device Output | 1 |
Torn Material | 1 |
Mechanical Problem | 1 |
Device Or Device Fragments Location Unknown | 1 |
Detachment Of Device Or Device Component | 1 |
Material Rupture | 1 |
Leak / Splash | 1 |
Optical Problem | 1 |
Hole In Material | 1 |
Failure To Power Up | 1 |
Material Separation | 1 |
False Device Output | 1 |
| Total Device Problems | 184 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Pentax Medical Company | II | Jun-28-2016 |