The following data is part of a premarket notification filed by Finemedix Co. Ltd. with the FDA for Clear-jet Injection Catheter.
| Device ID | K181690 |
| 510k Number | K181690 |
| Device Name: | Clear-Jet Injection Catheter |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | Finemedix Co. Ltd. 60, Maeyeo-ro, Dong-gu Daegu, KR 41065 |
| Contact | Hee Kyung Kwon |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-26 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809327352432 | K181690 | 000 |
| 18809327352422 | K181690 | 000 |
| 18809327352415 | K181690 | 000 |
| 18809327352408 | K181690 | 000 |
| 18809327352392 | K181690 | 000 |
| 18809327352385 | K181690 | 000 |
| 08809327351084 | K181690 | 000 |
| 18809327350671 | K181690 | 000 |
| 18809327350664 | K181690 | 000 |