The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Sureclip(tm) Repositionable Hemostasis Clip.
| Device ID | K161463 |
| 510k Number | K161463 |
| Device Name: | SureClip(TM) 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 | 2016-05-26 |
| Decision Date | 2017-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503530788 | K161463 | 000 |
| 16932503530658 | K161463 | 000 |
| 16932503530641 | K161463 | 000 |
| 16932503530634 | K161463 | 000 |
| 16932503530627 | K161463 | 000 |
| 16932503530610 | K161463 | 000 |
| 16932503530603 | K161463 | 000 |
| 16932503530597 | K161463 | 000 |
| 16932503530580 | K161463 | 000 |
| 16932503530573 | K161463 | 000 |
| 16932503530566 | K161463 | 000 |
| 16932503530665 | K161463 | 000 |
| 16932503530672 | K161463 | 000 |
| 16932503530771 | K161463 | 000 |
| 16932503530764 | K161463 | 000 |
| 16932503530757 | K161463 | 000 |
| 16932503530740 | K161463 | 000 |
| 16932503530733 | K161463 | 000 |
| 16932503530726 | K161463 | 000 |
| 16932503530719 | K161463 | 000 |
| 16932503530702 | K161463 | 000 |
| 16932503530696 | K161463 | 000 |
| 16932503530689 | K161463 | 000 |
| 16932503530559 | K161463 | 000 |