K193664 is an FDA 510(k) clearance for the SubQKath Catheter and Needle Set. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Hk Surgical (San Clemente, US). The FDA issued a Cleared decision on September 9, 2020, 253 days after receiving the submission on December 31, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K193664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2019 |
| Decision Date | September 09, 2020 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSO - Catheter, Conduction, Anesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |