The following data is part of a premarket notification filed by Finemedix Co., Ltd. with the FDA for Clearcap Distal Attachment.
| Device ID | K202616 |
| 510k Number | K202616 |
| Device Name: | ClearCap Distal Attachment |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Finemedix Co., Ltd. 60, Maeyeo-ro, Dong-gu Daegu, KR 41065 |
| Contact | Seok-jun Ma |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-09 |
| Decision Date | 2021-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809327352859 | K202616 | 000 |
| 18809327352842 | K202616 | 000 |
| 18809327352835 | K202616 | 000 |
| 18809327352828 | K202616 | 000 |
| 18809327352811 | K202616 | 000 |
| 18809327352804 | K202616 | 000 |
| 18809327350633 | K202616 | 000 |