Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
FDA 510(k) clearance K212355 · decided 2021-08-26
Clearance details
- K-number
- K212355
- Device name
- Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
- Applicant
- Checkpoint Surgical
- Decision
- Substantially Equivalent
- Date received
- 2021-07-29
- Decision date
- 2021-08-26
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Independence, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intr recall (Z-1466-2025) | Checkpoint Surgical Inc | 2025-03-26 |
| Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intr recall (Z-1467-2025) | Checkpoint Surgical Inc | 2025-03-26 |