Single Use Electrosurgical Snare SD-400
FDA 510(k) clearance K172734 · decided 2017-12-07
Clearance details
- K-number
- K172734
- Device name
- Single Use Electrosurgical Snare SD-400
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-11
- Decision date
- 2017-12-07
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- FDI
- 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: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Elect recall (Z-0482-2026) | Olympus Corporation of the Americas | 2025-11-07 |
| Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Singl recall (Z-0483-2026) | Olympus Corporation of the Americas | 2025-11-07 |