K924128 is an FDA 510(k) clearance for the CHOLANGIOGRAPHY CATHETER. This device is classified as a Catheter, Cholangiography (Class I - General Controls, product code GBZ).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on February 10, 1993, 177 days after receiving the submission on August 17, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K924128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1992 |
| Decision Date | February 10, 1993 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBZ — Catheter, Cholangiography |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |