FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UTERINE INJECTOR
K Number: K022503
·
Decision Oct 25, 2002
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
2
Review Days
88
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
- UTERINE INJECTOR
- K Number
- K022503
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thomas Medical, Inc.
- Date Received
- July 29, 2002
- Decision Date
- October 25, 2002
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKF), ordered by most recent decision date.
FemVue® Controlled Saline-Air Device (FSA-300)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RELIEEV HSG Catheter (HSG7FA1)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FemVue MINI Saline-Air Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RELIEEV Uterine Manipulator Injector (CUMI 5.0)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FemChec Controlled Saline-Air Device (FCD-250)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Rejoni Intrauterine Catheter
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Thomas Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022593 | THOMAS MEDICAL ELECTRODES | Nov 1, 2002 | Substantially Equivalent |