The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Laparoscopic Cholangiocath.
| Device ID | K911487 |
| 510k Number | K911487 |
| Device Name: | LAPAROSCOPIC CHOLANGIOCATH |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Contact | Dean Secrest |
| Correspondent | Dean Secrest UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-04 |
| Decision Date | 1991-08-14 |