K926217 is an FDA 510(k) clearance for the TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE, a Catheter, Cholangiography (Class I — General Controls, product code GBZ), submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 13, 1993, 215 days after receiving the submission on December 10, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K926217 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 10, 1992 |
| Decision Date | July 13, 1993 |
| Days to Decision | 215 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GBZ — Catheter, Cholangiography |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4200 |