K924212 is an FDA 510(k) clearance for the STRYKER ENDOSCOPY CHOLANGIOGRAM KIT. This device is classified as a Catheter, Cholangiography (Class I - General Controls, product code GBZ).
Submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on July 7, 1993, 321 days after receiving the submission on August 20, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K924212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 20, 1992 |
| Decision Date | July 07, 1993 |
| Days to Decision | 321 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 |