510(k) K182408 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, May 15, 2019 |
| Received | Sep 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182408
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2026 | Olympus Corporation of the Americas Brand Name: Single Use Electrosurgical Knife KD-645
Product Name: Olympus Single Use Electrosurgical Knife KD-645
Model/Catalog Number: KD-645L
Product Description: An electrosurgical device consistin Open, Classified |
KNS | None listed |
| Sep 12, 2024 | Olympus Corporation of the Americas Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract
Model: KD-640L Open, Classified |
KNS | None listed |
| Sep 12, 2024 | Olympus Corporation of the Americas Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract
Model: KD-645L Open, Classified |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.