FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGHMED ROOLIP MANIPULATOR
K Number: K110819
·
Decision Oct 5, 2011
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
17
Applicant Total
1
Review Days
196
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
- SINGHMED ROOLIP MANIPULATOR
- K Number
- K110819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1640
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J.Singh Instruments
- Date Received
- March 23, 2011
- Decision Date
- October 5, 2011
- Product Code
- HEW
- 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 |
|---|---|---|---|
| HEW | Culdoscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HEW), ordered by most recent decision date.
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Advincula Delineator Uterine Manipulator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Transvaginal Access Platform
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Advincula Delineator Uterine Manipulator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ColpoWave Colpotomizer and CerviGrip Uterine Manipulator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GelPOINT Transvaginal Access Platform
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology