K243820 is an FDA 510(k) clearance for the Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250. This device is classified as a Endoscopic Access Overtube, Gastroenterology-urology (Class II - Special Controls, product code FED).
Submitted by Dornier Medtech America (Kennesaw, US). The FDA issued a Cleared decision on January 31, 2025, 50 days after receiving the submission on December 12, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation..
| 510(k) Number | K243820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2024 |
| Decision Date | January 31, 2025 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FED - Endoscopic Access Overtube, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation. |