K921818 is an FDA 510(k) clearance for the ABBOTT SMART CAP. This device is classified as a Set, Administration, For Peritoneal Dialysis, Disposable (Class II - Special Controls, product code KDJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 28, 1994, 712 days after receiving the submission on April 15, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K921818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1992 |
| Decision Date | March 28, 1994 |
| Days to Decision | 712 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDJ — Set, Administration, For Peritoneal Dialysis, Disposable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |