Table, Cystometric, Electric
FDA product code MMZ · Class II (moderate risk) · 21 CFR 876.4890 · Gastroenterology, Urology
4510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033335 | Lithostar Modularis with Shockwave System CplusMMZ · Special | Siemens Medical Solutions USA, Inc. | 11/25/2003SE |
| K954278 | Beta Multi-Procedure Mobile Urological Table, Model S5005MMZ · Traditional | Beta Medical Products, Inc. | 10/02/1995SE |
| K942445 | Synergy IIMMZ · Traditional | Synectics Medical, Inc. | 11/22/1994SE |
| K942485 | MDT Urology TableMMZ · Traditional | Mdt Corp., Inc. | 08/26/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1894-2017 Class II | Sonesta S2; Article numbers: 525-S2-110V and 525S2-220VThe user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient… | Sonesta Medical Ab | 03/08/2017Terminated |
| Z-0566-2010 | Stille Sonesta Gynecology and Urology Table 6303 ; an electric cystometric table; Stille…There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories… | Stille AB | 11/03/2009Terminated |
| Z-0565-2010 | Stille Sonesta Gynecology and Urology Table 6302 and 6302U; an electric cystometric…There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories… | Stille AB | 11/03/2009Terminated |
| Z-0564-2010 | Stille Sonesta Urodynamic Table 6202 Gynecology/Urology Procedure Chair; an electric…There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories… | Stille AB | 11/03/2009Terminated |
| Z-0168-2007 | Modularis URO urological table Model number 5531012Potential pinch point with the patient table | Siemens Medical Solutions USA, Inc | 10/01/2006Terminated |