K771212 is an FDA 510(k) clearance for the SAFEED DISP. PLASTIC CATHETER. This device is classified as a Accessories, Catheter, G-u (Class II - Special Controls, product code KNY).
Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977, 69 days after receiving the submission on July 5, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K771212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1977 |
| Decision Date | September 12, 1977 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNY — Accessories, Catheter, G-u |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |