FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
San Antonio Stopcock
K Number: K181712
·
Decision Jul 26, 2018
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
71
Applicant Total
175
Review Days
28
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Basic Information
- Device Name
- San Antonio Stopcock
- K Number
- K181712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- June 28, 2018
- Decision Date
- July 26, 2018
- 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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