Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
FDA 510(k) clearance K182408 · decided 2019-05-15
Clearance details
- K-number
- K182408
- Device name
- Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-04
- Decision date
- 2019-05-15
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- KNS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Elect recall (Z-1223-2026) | Olympus Corporation of the Americas | 2026-01-30 |
| Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electr recall (Z-1547-2024) | Olympus Corporation of the Americas | 2024-09-12 |
| Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electr recall (Z-1548-2024) | Olympus Corporation of the Americas | 2024-09-12 |