The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Flexible Video-urethro-cystoscope System.
| Device ID | K062918 |
| 510k Number | K062918 |
| Device Name: | KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM |
| Classification | Cystourethroscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Contact | Susie Chen |
| Correspondent | Susie Chen KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2007-01-17 |
| Summary: | summary |