FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UTERINE ASPIRATION CURETTES(RIGID&FLEX)
K Number: K812426
·
Decision Oct 8, 1981
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
8
Review Days
44
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 ASPIRATION CURETTES(RIGID&FLEX)
- K Number
- K812426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1175
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Spec
- Date Received
- August 25, 1981
- Decision Date
- October 8, 1981
- Product Code
- HHK
- 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 |
|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHK), ordered by most recent decision date.
Uterine Aspiration Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CrossGlide ETS Plus
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CrossBay Endometrial Tissue Sampler (ETS)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
THE PANPAC SUCTION CURETTE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Medi-Spec
| K Number | Device Name | ||
|---|---|---|---|
| K833068 | LAMINARIA JAPONICA CERVICAL DILATOR | Feb 4, 1984 | Substantially Equivalent |
| K812694 | WHISK-R | Oct 26, 1981 | Substantially Equivalent |
| K801554 | STERILE CAST PADDING | Aug 4, 1980 | Substantially Equivalent |
| K800404 | MEDSPEC OPERATIVE OPTHALMIC KIT | Apr 24, 1980 | Substantially Equivalent |
| K800490 | STERILE DRESSING PACK | Mar 12, 1980 | Substantially Equivalent |
| K790952 | CLAMP COVERS | Jun 5, 1979 | Substantially Equivalent |
| K780548 | DISPOSA-LOOPS | Aug 21, 1978 | Substantially Equivalent |