Submission Details
| 510(k) Number | K100950 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 2010 |
| Decision Date | July 13, 2010 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
Cleared
Traditional
K100950 - VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
(FDA 510(k) Clearance)
Jul 2010
Decision
98d
Days
Class 2
Risk
K100950 is an FDA 510(k) clearance for the VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Venner Medical (Singapore) Pte, Ltd. (Dallas, US). The FDA issued a Cleared decision on July 13, 2010, 98 days after receiving the submission on April 6, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.
Device Classification
| Product Code | BTO — Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5800 |
Similar Devices — BTO Tube, Tracheostomy (w/wo Connector)
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