510(k) K955650 ยท FDI Snare, Flexible
OLYMPUS SD SERIES SNARES
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Mar 29, 1996 |
| Received | Dec 12, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955650
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2021 | Aomori Olympus Co., Ltd. SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
FAS | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
FAS | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
FAS | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract. Terminated |
FAS | None listed |
| Aug 18, 2010 | Olympus America Inc. Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15.
To be used with Ol Terminated |
FDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.