The following data is part of a premarket notification filed by Finemedix Co. Ltd. with the FDA for Clear-tip Eus-fna.
| Device ID | K180363 |
| 510k Number | K180363 |
| Device Name: | Clear-Tip EUS-FNA |
| Classification | Biopsy Needle |
| Applicant | Finemedix Co. Ltd. 60, Maeyeo-ro, Dong-gu Daegu, KR 41065 |
| Contact | Heon Sik Lee |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-09 |
| Decision Date | 2018-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809327352972 | K180363 | 000 |
| 18809327352965 | K180363 | 000 |
| 18809327352958 | K180363 | 000 |
| 18809327352941 | K180363 | 000 |
| 18809327352934 | K180363 | 000 |
| 18809327352927 | K180363 | 000 |