The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Sureclip Repositionable Hemostasis Clip.
| Device ID | K182556 |
| 510k Number | K182556 |
| Device Name: | SureClip Repositionable Hemostasis Clip |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Micro-Tech (Nanjing) CO., Ltd. NO. 10 Gaoke Third Road Nanjing, CN 210032 |
| Contact | Becky Li |
| Correspondent | Becky Li Micro-Tech (Nanjing) CO., Ltd. NO. 10 Gaoke Third Road Nanjing, CN 210032 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-17 |
| Decision Date | 2018-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503530467 | K182556 | 000 |
| 16932503530511 | K182556 | 000 |
| 46932503530345 | K182556 | 000 |
| 46932503530338 | K182556 | 000 |
| 26932503530389 | K182556 | 000 |
| 26932503530372 | K182556 | 000 |
| 26932503530365 | K182556 | 000 |
| 26932503530358 | K182556 | 000 |
| 26932503530341 | K182556 | 000 |
| 16932503530528 | K182556 | 000 |
| 16932503530535 | K182556 | 000 |
| 16932503530450 | K182556 | 000 |
| 16932503530443 | K182556 | 000 |
| 16932503530436 | K182556 | 000 |
| 16932503530429 | K182556 | 000 |
| 16932503530412 | K182556 | 000 |
| 16932503530405 | K182556 | 000 |
| 16932503530399 | K182556 | 000 |
| 16932503530542 | K182556 | 000 |
| 26932503530334 | K182556 | 000 |