K970946 is an FDA 510(k) clearance for the MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET. This device is classified as a System, Irrigation, Urological (Class II - Special Controls, product code LJH).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on June 10, 1997, 88 days after receiving the submission on March 14, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K970946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1997 |
| Decision Date | June 10, 1997 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJH — System, Irrigation, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |