Ndo Surgical, Inc.
Medical device manufacturer in Mansfield, MA.
6510(k) clearances
0PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K073671 | Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture…OCW · Traditional | 03/26/2008SE |
| K072125 | Endoscopic Plication System, Eps, Eplicator, Plicator InstrumentODE · Traditional | 10/18/2007SE |
| K071553 | Endoscopic Plication System; Eps; PlicatorODE · Traditional | 09/18/2007SE |
| K032820 | Modification to Endoscopic Plication SystemODE · Special | 10/23/2003SE |
| K031262 | Endoscopic Plication System, Model 160-00760ODE · Special | 05/23/2003SE |
| K023234 | Endoscopic Plication SystemODE · Traditional | 04/17/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0685-2007 | Plicator EPS Plication System Catalog Number: 160-01128RDevice arm may fail to open after being deployed and require surgical intervention to remove | 01/26/2007Terminated |