K212355 is an FDA 510(k) clearance for the Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Checkpoint Surgical (Independence, US). The FDA issued a Cleared decision on August 26, 2021, 28 days after receiving the submission on July 29, 2021.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K212355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2021 |
| Decision Date | August 26, 2021 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN - Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |