POWERSEAL Curved Jaw Sealer and Divider, Double Action
FDA 510(k) clearance K212643 · decided 2021-09-27
Clearance details
- K-number
- K212643
- Device name
- POWERSEAL Curved Jaw Sealer and Divider, Double Action
- Applicant
- Olympus Surgical Technologies America
- Decision
- Substantially Equivalent
- Date received
- 2021-08-20
- Decision date
- 2021-09-27
- Days to decision
- 38 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Brooklyn Park, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use i recall (Z-1699-2024) | Olympus Corporation of the Americas | 2024-04-30 |
| POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use i recall (Z-1700-2024) | Olympus Corporation of the Americas | 2024-04-30 |
| POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use i recall (Z-1701-2024) | Olympus Corporation of the Americas | 2024-04-30 |
| Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0 recall (Z-1813-2022) | Olympus Corporation of the Americas | 2022-09-26 |
| Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0 recall (Z-1814-2022) | Olympus Corporation of the Americas | 2022-09-26 |
| Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0 recall (Z-1815-2022) | Olympus Corporation of the Americas | 2022-09-26 |