Definition: To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.
| Device Type ID | 2061 |
| Device Name | Anti Fog Solution And Accessories, Endoscopy |
| Physical State | Anti Fog Solution; Applicator- Typically A Foam Pad Or Sponge, Spray Can, Bottle, Or Cloth; Container To Hold Solution |
| Technical Method | Apply Solution To Lens, Typically By Spraying Or Wiping. |
| Target Area | Endoscopic Lens |
| 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) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2061 |
| Device | Anti Fog Solution And Accessories, Endoscopy |
| Product Code | OCT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 4 |
Detachment Of Device Or Device Component | 4 |
Break | 3 |
Failure To Power Up | 3 |
Material Separation | 1 |
Device Packaging Compromised | 1 |
Device Or Device Fragments Location Unknown | 1 |
Component Falling | 1 |
Corroded | 1 |
Product Quality Problem | 1 |
Material Integrity Problem | 1 |
Device Operates Differently Than Expected | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 23 |