FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
K Number: K222734
·
Decision Nov 8, 2022
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
3
Review Days
60
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
- K Number
- K222734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diversatek Healthcare
- Date Received
- September 9, 2022
- Decision Date
- November 8, 2022
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCX), ordered by most recent decision date.
AUXILIARY WATER TUBE MAJ-855
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single-Use Biopsy Valve (MAJ-1555)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ArgoCap (200.52)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endoscopic Water Pump
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Water Container (MAJ-901); Water Container (MAJ-902)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Aspiration Catheter (2189)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology