510(k) K032820 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
| Applicant | Ndo Surgical, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Oct 23, 2003 |
| Received | Sep 10, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032820
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2007 | NDO Surgical, Inc. Plicator EPS Plication System
Catalog Number: 160-01128R Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.