510(k) K052194 ยท ODF Mini Endoscope, Gastroenterology-Urology
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Aug 24, 2005 |
| Received | Aug 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2007 | Boston Scientific Corporation Boston Scientific SpyGlass Visualization Probe
Reference Number: 4603 UPN M00546030 Terminated |
KOG | None listed |
| Mar 31, 2007 | Boston Scientific Corporation Boston Scientific SpyGlass Ocular
Reference Number: 4604 UPN M00546040 Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.