K813487 is an FDA 510(k) clearance for the CATHETER BUBBLE STAND. This device is classified as a System, Peritoneal, Automatic Delivery (Class II — Special Controls, product code FKX).
Submitted by Accurate Surgical Instruments Co. (Walker, US). The FDA issued a Cleared decision on December 31, 1981, 30 days after receiving the submission on December 1, 1981.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K813487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1981 |
| Decision Date | December 31, 1981 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKX — System, Peritoneal, Automatic Delivery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |