510(k) K071254 ยท FDA Enteroscope And Accessories
SMALL INTESTINAL VIDEOSCOPE SYSTEM
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Mar 25, 2008 |
| Received | May 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071254
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Small intestinal videoscope-For endoscopy and endoscopic surgery within the
upper digestive tract (including the esophagus, stomach, duodenum, and small
intestine) by oral insertion or the lower diges Open, Classified |
NWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.