Ndo Surgical, Inc.
Mansfield, MA, US
Ndo Surgical, Inc. appears in FDA device records in Mansfield, MA. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Ndo Surgical, Inc. between 2003 and 2008. The busiest year on record is 2003, with 3. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 3 |
| 2007 | 2 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K073671 | PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE | OCW | Substantially Equivalent | |
| K072125 | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT | ODE | Substantially Equivalent | |
| K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | ODE | Substantially Equivalent | |
| K032820 | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM | ODE | Substantially Equivalent | |
| K031262 | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 | ODE | Substantially Equivalent | |
| K023234 | ENDOSCOPIC PLICATION SYSTEM | ODE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0685-2007 | Plicator EPS Plication System Catalog Number: 160-01128R | Device arm may fail to open after being deployed and require surgical intervention to remove | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain