The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Clearpetra Suction-evacuation Sheath.
| Device ID | K203119 |
| 510k Number | K203119 |
| Device Name: | ClearPetra Suction-Evacuation Sheath |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Well Lead Medical Co., LTD. C-4# Jinhu Industrial Estate, Hualong, Panyu Guangzhou, CN 511434 |
| Contact | Jenny Zhu |
| Correspondent | Jenny Zhu Well Lead Medical Co., LTD. C-4# Jinhu Industrial Estate, Hualong, Panyu Guangzhou, CN 511434 |
| Product Code | FED |
| Subsequent Product Code | FAJ |
| Subsequent Product Code | FGA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-16 |
| Decision Date | 2020-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16944932740683 | K203119 | 000 |
| 16944932748504 | K203119 | 000 |
| 16944932748498 | K203119 | 000 |
| 16944932748481 | K203119 | 000 |
| 16944932748474 | K203119 | 000 |
| 16944932748467 | K203119 | 000 |
| 16944932748450 | K203119 | 000 |
| 16944932748443 | K203119 | 000 |
| 16944932748436 | K203119 | 000 |
| 16944932748429 | K203119 | 000 |
| 16944932748412 | K203119 | 000 |
| 16944932748405 | K203119 | 000 |
| 16944932748399 | K203119 | 000 |
| 16944932748382 | K203119 | 000 |
| 16944932748511 | K203119 | 000 |
| 16944932740546 | K203119 | 000 |
| 16944932740676 | K203119 | 000 |
| 16944932740669 | K203119 | 000 |
| 16944932740652 | K203119 | 000 |
| 16944932740645 | K203119 | 000 |
| 16944932740638 | K203119 | 000 |
| 16944932740621 | K203119 | 000 |
| 16944932740614 | K203119 | 000 |
| 16944932740607 | K203119 | 000 |
| 16944932740591 | K203119 | 000 |
| 16944932740584 | K203119 | 000 |
| 16944932740577 | K203119 | 000 |
| 16944932740560 | K203119 | 000 |
| 16944932740553 | K203119 | 000 |
| 16944932748375 | K203119 | 000 |