FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
EndoClot
K Number: K191254
·
Decision Jan 30, 2020
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
3
Review Days
265
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Basic Information
- Device Name
- EndoClot
- K Number
- K191254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endoclot Plus Co., Ltd.
- Date Received
- May 10, 2019
- Decision Date
- January 30, 2020
- Product Code
- PLL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLL | Submucosal Injection Agent | FDA class 2 | Gastroenterology, Urology |
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