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 | 1932 |
Device Name | Esophagoscope, General & Plastic Surgery |
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 | GCL |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 1932 |
Device | Esophagoscope, General & Plastic Surgery |
Product Code | GCL |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Endoscope And Accessories. |
CFR Regulation Number | 876.1500 [🔎] |
Device Problems | |
---|---|
Break | 7 |
Device Issue | 4 |
Total Device Problems | 11 |