The following data is part of a premarket notification filed by Checkpoint Surgical with the FDA for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large.
| Device ID | K212355 |
| 510k Number | K212355 |
| Device Name: | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large |
| Classification | Stimulator, Nerve |
| Applicant | Checkpoint Surgical 6050 Oak Tree Blvd., Suite 360 Independence, OH 44131 |
| Contact | Ben Cottrill |
| Correspondent | Ben Cottrill Checkpoint Surgical 6050 Oak Tree Blvd., Suite 360 Independence, OH 44131 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-29 |
| Decision Date | 2021-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B13095251 | K212355 | 000 |
| B13095241 | K212355 | 000 |