The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz 10.5 Fr. Flexible Hysteroscope.
| Device ID | K961605 |
| 510k Number | K961605 |
| Device Name: | KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-25 |
| Decision Date | 1996-11-13 |
| Summary: | summary |