The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc with the FDA for Telepack +.
| Device ID | K221174 |
| 510k Number | K221174 |
| Device Name: | Telepack + |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | KARL STORZ Endoscopy America, Inc 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Mario Trujillo |
| Correspondent | Mario Trujillo KARL STORZ Endoscopy America, Inc 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-05-13 |