510(k) K011151 ยท FDS Gastroscope And Accessories, Flexible/Rigid
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
| Applicant | The Olympus Optical Co., Melville NY, US |
| Decision | Substantially Equivalent, May 15, 2001 |
| Received | Apr 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011151
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170 Open, Classified |
FDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.