510(k) K111788 ยท HET Laparoscope, Gynecologic (And Accessories)
ENDOEYE HD II
| Applicant | Olympus America, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Jan 13, 2012 |
| Received | Jun 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2017 | Olympus Corporation of the Americas Olympus ENDOEYE HD II Video Telescopes
Models:
WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable;
WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable;
repair cable 10mm 0/30 deg., part number W710 Terminated |
HET | None listed |
| Dec 10, 2015 | Olympus Corporation of the Americas Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes Terminated |
HET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.