K770490 is an FDA 510(k) clearance for the DRAINAGE BAG, IMPROVED, FLAT. This device is classified as a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II - Special Controls, product code KNX).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on March 21, 1977, 7 days after receiving the submission on March 14, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K770490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1977 |
| Decision Date | March 21, 1977 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNX — Collector, Urine, (and Accessories) For Indwelling Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |