The following data is part of a premarket notification filed by Geny Medical, Inc. with the FDA for Genyx Flexible Injection Neeedle.
| Device ID | K001146 |
| 510k Number | K001146 |
| Device Name: | GENYX FLEXIBLE INJECTION NEEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | GENY MEDICAL, INC. 66 ARGONAUT # 170 Aliso Viejo, CA 92656 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon GENY MEDICAL, INC. 66 ARGONAUT # 170 Aliso Viejo, CA 92656 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-06-30 |