Extended Reservoir
FDA 510(k) clearance K210714 · decided 2022-04-06
Clearance details
- K-number
- K210714
- Device name
- Extended Reservoir
- Applicant
- Medtronic Minimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-03-10
- Decision date
- 2022-04-06
- Days to decision
- 392 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Northridge, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MiniMed 670G System (P160017/S133) | Medtronic Minimed, Inc. | 2025-12-18 |
| MiniMed 780G System (P160017/S125) | Medtronic Minimed, Inc. | 2025-12-11 |
| MiniMed 670G system MiniMed 770G system MiniMed 780G system (P160017/S131) | Medtronic Minimed, Inc. | 2025-12-10 |
| Simplera Sync Sensor; Guardian 4 Sensor (P250012/S005) | Medtronic Minimed, Inc. | 2025-12-10 |
| MiniMed 780G System (P160017/S134) | Medtronic Minimed, Inc. | 2025-12-08 |
| Simplera Sync Sensor (P250012/S007) | Medtronic Minimed, Inc. | 2025-12-08 |
| Simplera Sync Sensor (P250012/S006) | Medtronic Minimed, Inc. | 2025-12-05 |
| MiniMed 780G System (P160017/S132) | Medtronic Minimed, Inc. | 2025-12-05 |