| Device Type ID | 2000 |
| Device Name | Accessories, Cleaning Brushes, For Endoscope |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MNL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2000 |
| Device | Accessories, Cleaning Brushes, For Endoscope |
| Product Code | MNL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Break | 39 |
Brush | 25 |
Detachment Of Device Component | 13 |
Detachment Of Device Or Device Component | 4 |
Entrapment Of Device | 4 |
Device Contaminated During Manufacture Or Shipping | 3 |
Use Of Device Problem | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Human Factors Issue | 2 |
Material Fragmentation | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Premature Activation | 1 |
Microbial Contamination Of Device | 1 |
Facilities Issue | 1 |
Device Reprocessing Problem | 1 |
Device Operates Differently Than Expected | 1 |
Stent | 1 |
Endoscope | 1 |
Retraction Problem | 1 |
Difficult Or Delayed Positioning | 1 |
Device Displays Incorrect Message | 1 |
Connection Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Application Program Freezes, Becomes Nonfunctional | 1 |
| Total Device Problems | 110 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cygnus Medical | III | Apr-14-2016 |
| 2 | Karl Storz Endovision, Inc. | II | Oct-02-2018 |
| 3 | Madison Polymeric Engineering | II | Feb-28-2019 |
| 4 | Madison Polymeric Engineering | II | May-18-2018 |
| 5 | Madison Polymeric Engineering | II | Mar-26-2018 |
| 6 | Medline Industries Inc | II | Oct-11-2018 |