The following data is part of a premarket notification filed by G-flex Europe Sprl with the FDA for Cysto-gastro-sets.
| Device ID | K211909 |
| 510k Number | K211909 |
| Device Name: | Cysto-Gastro-Sets |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | G-Flex Europe SPRL 20, Rue De L’industrie Nivelles, BE 1400 |
| Contact | Thierry Cremer |
| Correspondent | Thierry Cremer G-Flex Europe SPRL 20, Rue De L’industrie Nivelles, BE 1400 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2022-06-09 |