Device Type ID | 1727 |
Device Name | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
Regulation Description | Urodynamics Measurement System. |
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 | 876.1620 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | FAP |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1727 |
Device | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
Product Code | FAP |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Urodynamics Measurement System. |
CFR Regulation Number | 876.1620 [🔎] |
Device Problems | |
---|---|
Device Contaminated During Manufacture Or Shipping | 1 |
Material Rupture | 1 |
Total Device Problems | 2 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Teleflex Medical Europe Ltd | II | Apr-12-2018 |