510(k) K092309 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Oct 30, 2009 |
| Received | Jul 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092309
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2026 | Olympus Corporation of the Americas Brand Name: Single Use Electrosurgical Knife
Product Name: Olympus Single Use Electrosurgical Knife KD-640L
Model/Catalog Number: KD640-L
Product Description: An electrosurgical device consisting of a Open, Classified |
KNS | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - 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-612L ELECTROSURGICAL KNIFE, model no. KD-612L - 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-612U ELECTROSURGICAL SNARE, model no. KD-612U - 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-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - 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-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - 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-640L ELECTROSURGICAL SNARE, model no. KD-640L - 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-650L ELECTROSURGICAL SNARE, model no. KD-650L - 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-650U ELECTROSURGICAL SNARE, model no. KD-650U - 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.