The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Laparoscopic Cholangiogram Catheter Kit.
| Device ID | K915506 |
| 510k Number | K915506 |
| Device Name: | LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9300 PROGRESS PKWY. Mentor, OH 44060 |
| Contact | Lisa M Scholz |
| Correspondent | Lisa M Scholz UNITED STATES ENDOSCOPY GROUP, INC. 9300 PROGRESS PKWY. Mentor, OH 44060 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-03-06 |