The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Hopkins (ksh) I Rigid Telescope, Ksh Ii Rigid Telescope, Ksh Rigid Operating Scopes Karl Storz Oval Sheath.
| Device ID | K935277 |
| 510k Number | K935277 |
| Device Name: | KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Susie S Chen |
| Correspondent | Susie S Chen KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-03 |
| Decision Date | 1994-09-16 |