FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Irrigation Tubing with CO2 or Air
K Number: K193250
·
Decision Apr 6, 2020
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
1
Review Days
133
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Basic Information
- Device Name
- Irrigation Tubing with CO2 or Air
- K Number
- K193250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Keymed (Medical and Industrial Equipment) , Ltd.
- Date Received
- November 25, 2019
- Decision Date
- April 6, 2020
- Product Code
- OCX
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
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