The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Flex-thor Scope.
| Device ID | K183264 |
| 510k Number | K183264 |
| Device Name: | Flex-THOR Scope |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue Ei Segundo, CA 90245 |
| Contact | Nozomi Yagi |
| Correspondent | Nozomi Yagi KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue Ei Segundo, CA 90245 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-23 |
| Decision Date | 2019-01-18 |
| Summary: | summary |