K915506 is an FDA 510(k) clearance for the LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT. This device is classified as a Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (Class II - Special Controls, product code GCA).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 6, 1992, 88 days after receiving the submission on December 9, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K915506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 09, 1991 |
| Decision Date | March 06, 1992 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | GCA - Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |