K961711 is an FDA 510(k) clearance for the ASPISAFE GASTRIC TUBE. This device is classified as a Tube, Nasogastric (Class II - Special Controls, product code BSS).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on June 11, 1997, 405 days after receiving the submission on May 2, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K961711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1996 |
| Decision Date | June 11, 1997 |
| Days to Decision | 405 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 |