510(k) K984358 ยท FDS Gastroscope And Accessories, Flexible/Rigid
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Sep 17, 1999 |
| Received | Dec 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984358
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2023 | Aomori Olympus Co., Ltd. Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.
Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012 Open, Classified |
FDS | None listed |
| Sep 7, 2023 | Aomori Olympus Co., Ltd. Reusable distal attachments
Models:
MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290 Open, Classified |
FDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.