K191602 is an FDA 510(k) clearance for the APA Oxy Blade. This device is classified as a Laryngoscope, Rigid (Class I - General Controls, product code CCW).
Submitted by Venner Medical (Singapore) Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on August 2, 2019, 46 days after receiving the submission on June 17, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5540.
| 510(k) Number | K191602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2019 |
| Decision Date | August 02, 2019 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCW - Laryngoscope, Rigid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5540 |