The following data is part of a premarket notification filed by Karl Storz Imaging, Inc. with the FDA for Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera For Endoscopic Procedures.
| Device ID | K950862 |
| 510k Number | K950862 |
| Device Name: | KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ IMAGING, INC. 175 CREMONA DR. Goleta, CA 93117 |
| Contact | Terry Fernandez |
| Correspondent | Terry Fernandez KARL STORZ IMAGING, INC. 175 CREMONA DR. Goleta, CA 93117 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-05-24 |