510(k) K212355 ยท ETN Stimulator, Nerve
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
| Applicant | Checkpoint Surgical, Independence OH, US |
| Decision | Substantially Equivalent, Aug 26, 2021 |
| Received | Jul 29, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2025 | Checkpoint Surgical Inc Brand Name: Checkpoint Guardian Intraoperative Lead
Product Name: Checkpoint Guardian Intraoperative Lead, Small
Model/Catalog Number: REF# 9524 (Small)
Product Description: The Checkpoint Guardian In Open, Classified |
ETN | None listed |
| Mar 26, 2025 | Checkpoint Surgical Inc Brand Name: Checkpoint Guardian Intraoperative Lead
Product Name: Checkpoint Guardian Intraoperative Lead, Medium
Model/Catalog Number: REF# 9525 (Medium)
Product Description: The Checkpoint Guardian Open, Classified |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.