FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Endoscope Valves System
K Number: K232244
·
Decision Nov 29, 2023
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
71
Applicant Total
3
Review Days
124
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Basic Information
- Device Name
- Disposable Endoscope Valves System
- K Number
- K232244
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Changzhou Endoclean Medical Device Co., Ltd.
- Date Received
- July 28, 2023
- Decision Date
- November 29, 2023
- Product Code
- ODC
- 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 |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | FDA class 2 | Gastroenterology, Urology |
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