K943361 is an FDA 510(k) clearance for the NORTHGATE FLOW ASSIST TUBING FOR UROLOGY. This device is classified as a System, Irrigation, Urological (Class II - Special Controls, product code LJH).
Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on September 29, 1995, 443 days after receiving the submission on July 13, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K943361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1994 |
| Decision Date | September 29, 1995 |
| Days to Decision | 443 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LJH — System, Irrigation, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |