510(k) K171158 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Single Use Electrosurgical knife
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Nov 17, 2017 |
| Received | Apr 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2021 | Aomori Olympus Co., Ltd. KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. Terminated |
KNS | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract. Terminated |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.