The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Lockado Repositionable Hemostasis Clip.
| Device ID | K202333 |
| 510k Number | K202333 |
| Device Name: | Lockado 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 | Sally He |
| Correspondent | Sally He 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 | 2020-08-17 |
| Decision Date | 2021-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503530832 | K202333 | 000 |
| 16932503530818 | K202333 | 000 |