The following data is part of a premarket notification filed by Apriomed Ab with the FDA for Gangi-softguard Coaxial Needle, Gangi-hydroguard Coaxial Needle.
| Device ID | K181756 |
| 510k Number | K181756 |
| Device Name: | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle |
| Classification | Biopsy Needle |
| Applicant | AprioMed AB Virdings Alle 28 Uppsala, SE 75450 |
| Contact | Katrin Svensson |
| Correspondent | Katrin Svensson AprioMed AB Virdings Alle 28 Uppsala, SE 75450 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2018-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27350031351365 | K181756 | 000 |
| 17350031350453 | K181756 | 000 |
| 17350031350446 | K181756 | 000 |
| 17350031350439 | K181756 | 000 |
| 17350031350422 | K181756 | 000 |
| 17350031350415 | K181756 | 000 |
| 17350031350408 | K181756 | 000 |
| 17350031350392 | K181756 | 000 |
| 17350031350385 | K181756 | 000 |
| 17350031350378 | K181756 | 000 |
| 17350031350361 | K181756 | 000 |
| 17350031350354 | K181756 | 000 |
| 17350031350347 | K181756 | 000 |
| 17350031350460 | K181756 | 000 |
| 27350031351198 | K181756 | 000 |
| 27350031351358 | K181756 | 000 |
| 27350031351341 | K181756 | 000 |
| 27350031351334 | K181756 | 000 |
| 27350031351297 | K181756 | 000 |
| 27350031351280 | K181756 | 000 |
| 27350031351273 | K181756 | 000 |
| 27350031351266 | K181756 | 000 |
| 27350031351259 | K181756 | 000 |
| 27350031351242 | K181756 | 000 |
| 27350031351235 | K181756 | 000 |
| 27350031351228 | K181756 | 000 |
| 27350031351211 | K181756 | 000 |
| 17350031350330 | K181756 | 000 |