K990504 is an FDA 510(k) clearance for the MEMOTHERM COLORECTAL STENT. This device is classified as a Stent, Colonic, Metallic, Expandable (Class II - Special Controls, product code MQR).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on March 16, 2000, 393 days after receiving the submission on February 17, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K990504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1999 |
| Decision Date | March 16, 2000 |
| Days to Decision | 393 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MQR — Stent, Colonic, Metallic, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |