The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Karl Storz Flexible Choledochoscope.
| Device ID | K942112 |
| 510k Number | K942112 |
| Device Name: | KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-02 |
| Decision Date | 1995-02-28 |