K220981 is an FDA 510(k) clearance for the SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe. This device is classified as a Dilator, Vessel, Surgical (Class II - Special Controls, product code DWP).
Submitted by Fehling Surgical Instruments, Inc. (Kennesaw, US). The FDA issued a Cleared decision on April 20, 2023, 381 days after receiving the submission on April 4, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4475.
| 510(k) Number | K220981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | April 20, 2023 |
| Days to Decision | 381 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWP — Dilator, Vessel, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4475 |