FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SELECTCELLS STANDARD
K Number: K954097
·
Decision Nov 21, 1995
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
6
Review Days
82
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Basic Information
- Device Name
- SELECTCELLS STANDARD
- K Number
- K954097
- 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
- August 31, 1995
- Decision Date
- November 21, 1995
- 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)
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RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
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FDA Class 2
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CrossGlide ETS Plus
FDA 510(k)
FDA Class 2
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CrossBay Endometrial Tissue Sampler (ETS)
FDA 510(k)
FDA Class 2
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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 |
| K974819 | SELECTCELLS(TM) MINI | Mar 23, 1998 | Substantially Equivalent |
| K954099 | SELECT IUI | Nov 22, 1995 | Substantially Equivalent |
| K954102 | SELECTMUCUS | Nov 21, 1995 | Substantially Equivalent |
| K942922 | SELECTA 20/60 CHEMISTRY ANALYZER | Jul 19, 1995 | Substantially Equivalent |