Company ยท US
Ndo Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2008. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2008 | K073671 | PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE Ndo Surgical, Inc. | OCW |
| Oct 18, 2007 | K072125 | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT Ndo Surgical, Inc. | ODE |
| Sep 18, 2007 | K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR Ndo Surgical, Inc. | ODE |
| Oct 23, 2003 | K032820 | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM Ndo Surgical, Inc. | ODE |
| May 23, 2003 | K031262 | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 Ndo Surgical, Inc. | ODE |
| Apr 17, 2003 | K023234 | ENDOSCOPIC PLICATION SYSTEM Ndo Surgical, Inc. | ODE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2007 | NDO Surgical, Inc. Plicator EPS Plication System
Catalog Number: 160-01128R Terminated |
KOG | K032820 |