The following data is part of a premarket notification filed by Agency For Medical Innovations Gmbh with the FDA for Fixcision.
| Device ID | K182664 |
| 510k Number | K182664 |
| Device Name: | FiXcision |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | Agency For Medical Innovations GmbH Im Letten 1 Feldkirch, AT 6800 |
| Contact | Martin Hohlrieder |
| Correspondent | Allison C. Komiyama AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave., Suite B-257 San Diego, CA 92110 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-25 |
| Decision Date | 2018-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EAMIFIX20011 | K182664 | 000 |