Definition: To Examine And Perform Procedures In Body Cavities Of The GI And GU Tract. 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, Avai
| Device Type ID | 2073 |
| Device Name | Mini Endoscope, Gastroenterology-urology |
| Physical State | May Include: Handle, Scope, Fiberoptic Attachment. Usually Modular In Nature. May Be Custom Built |
| Technical Method | Can Be Placed Through Working Channel Of A Full Sized Endoscope. May Also Be Used As A Stand Alone Device |
| Target Area | Various Body Cavities In The GI And GU Tract |
| 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 | ODF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2073 |
| Device | Mini Endoscope, Gastroenterology-urology |
| Product Code | ODF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |