FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SELECTCELLS(TM) MINI
K Number: K974819
·
Decision Mar 23, 1998
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
6
Review Days
90
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
- SELECTCELLS(TM) MINI
- K Number
- K974819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1175
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Select Medical Systems, Inc.
- Date Received
- December 23, 1997
- Decision Date
- March 23, 1998
- 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 Select Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012935 | THECURVE, ITEM 507 | Oct 11, 2001 | Substantially Equivalent |
| K954099 | SELECT IUI | Nov 22, 1995 | Substantially Equivalent |
| K954097 | SELECTCELLS STANDARD | Nov 21, 1995 | Substantially Equivalent |
| K954102 | SELECTMUCUS | Nov 21, 1995 | Substantially Equivalent |
| K942922 | SELECTA 20/60 CHEMISTRY ANALYZER | Jul 19, 1995 | Substantially Equivalent |