The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Hopkins I&ii/oper/autoclavable Telescopesq.
| Device ID | K943176 |
| 510k Number | K943176 |
| Device Name: | KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Susie S Chen |
| Correspondent | Susie S Chen KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FAJ |
| Subsequent Product Code | FBO |
| Subsequent Product Code | FGB |
| Subsequent Product Code | FGC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-01 |
| Decision Date | 1994-12-21 |