FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rejoni Intrauterine Catheter
K Number: K222798
·
Decision Dec 16, 2022
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
1
Review Days
91
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Basic Information
- Device Name
- Rejoni Intrauterine Catheter
- K Number
- K222798
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rejoni, Inc.
- Date Received
- September 16, 2022
- Decision Date
- December 16, 2022
- Product Code
- LKF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
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