The following data is part of a premarket notification filed by Finemedix Co., Ltd. with the FDA for Cleargrasp Snare.
| Device ID | K183289 |
| 510k Number | K183289 |
| Device Name: | ClearGrasp Snare |
| Classification | Snare, Flexible |
| 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 | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-26 |
| Decision Date | 2019-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809327351890 | K183289 | 000 |
| 18809327351708 | K183289 | 000 |
| 18809327351692 | K183289 | 000 |
| 18809327351685 | K183289 | 000 |
| 18809327351678 | K183289 | 000 |
| 18809327351661 | K183289 | 000 |
| 08809327351039 | K183289 | 000 |
| 18809327351029 | K183289 | 000 |
| 18809327351012 | K183289 | 000 |
| 18809327351005 | K183289 | 000 |
| 18809327350992 | K183289 | 000 |
| 18809327350985 | K183289 | 000 |
| 18809327350978 | K183289 | 000 |
| 18809327350961 | K183289 | 000 |
| 18809327350954 | K183289 | 000 |
| 18809327350947 | K183289 | 000 |
| 18809327350930 | K183289 | 000 |
| 18809327351715 | K183289 | 000 |
| 18809327351722 | K183289 | 000 |
| 18809327351883 | K183289 | 000 |
| 18809327351876 | K183289 | 000 |
| 18809327351869 | K183289 | 000 |
| 18809327351852 | K183289 | 000 |
| 18809327351845 | K183289 | 000 |
| 18809327351838 | K183289 | 000 |
| 18809327351821 | K183289 | 000 |
| 18809327351814 | K183289 | 000 |
| 18809327351807 | K183289 | 000 |
| 18809327351791 | K183289 | 000 |
| 18809327351784 | K183289 | 000 |
| 18809327351777 | K183289 | 000 |
| 18809327351760 | K183289 | 000 |
| 18809327351753 | K183289 | 000 |
| 18809327351746 | K183289 | 000 |
| 18809327351739 | K183289 | 000 |
| 18809327350923 | K183289 | 000 |