FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
K Number: K140753
·
Decision Jul 15, 2014
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
2
Review Days
111
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Basic Information
- Device Name
- ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
- K Number
- K140753
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medivators
- Date Received
- March 26, 2014
- Decision Date
- July 15, 2014
- 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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Other Clearances by Medivators
| K Number | Device Name | ||
|---|---|---|---|
| K231418 | ENDOGATOR Hybrid Irrigation Tubing | Aug 14, 2023 | Substantially Equivalent |