K142483 is an FDA 510(k) clearance for the TurboSEAL Nasogastric Aspiration Tube, a Tube, Nasogastric (Class II — Special Controls, product code BSS), submitted by Turboseal, L.P. (Tel Aviv, IL). The FDA issued a Cleared decision on December 19, 2014, 106 days after receiving the submission on September 4, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K142483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 04, 2014 |
| Decision Date | December 19, 2014 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | BSS — Tube, Nasogastric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |