EndoClot
Submucosal Injection Agent
EndoClot Plus Co., Ltd.
The following data is part of a premarket notification filed by Endoclot Plus Co., Ltd. with the FDA for Endoclot.
Pre-market Notification Details
| Device ID | K191254 |
| 510k Number | K191254 |
| Device Name: | EndoClot |
| Classification | Submucosal Injection Agent |
| Applicant | EndoClot Plus Co., Ltd. 101 Room, B8 Building, 218 Xinghu Street, Suzhou Industrial Park Suzhou, CN 215000 |
| Contact | Hendry Zhang |
| Correspondent | Jonathan Hu Medwheat (Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No. 33 Room 303 Shanghai, CN 200093 |
| Product Code | PLL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-10 |
| Decision Date | 2020-01-30 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26972011720216 | K191254 | 000 |
| 26972011720254 | K191254 | 000 |
| 26972011720247 | K191254 | 000 |
Trademark Results [EndoClot]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOCLOT 97292080 not registered Live/Pending |
EndoClot Plus, Inc. 2022-03-02 |
 ENDOCLOT 85322084 4412920 Live/Registered |
EndoClot Plus, Inc. 2011-05-16 |
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