The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea 15.5 Fr. Flexible Choledocho-fiberscope.
| Device ID | K971977 |
| 510k Number | K971977 |
| Device Name: | KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marlena Allen Piercy |
| Correspondent | Marlena Allen Piercy KARL STORZ ENDOSCOPY-AMERICA, INC. 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 | 1997-05-29 |
| Decision Date | 1997-08-12 |
| Summary: | summary |