Submission Details
| 510(k) Number | K191602 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
APA Oxy Blade
Aug 2019
Decision
46d
Days
Class 1
Risk
About This 510(k) Submission
K191602 is an FDA 510(k) clearance for the APA Oxy Blade, 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 review panel. Regulated under 21 CFR 868.5540.
Device Classification
| Product Code | CCW — Laryngoscope, Rigid |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5540 |
Manufacturer
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