FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINISPACE(TM) IUI CATHETER
K Number: K902171
·
Decision Oct 5, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
28
Applicant Total
129
Review Days
144
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
- MINISPACE(TM) IUI CATHETER
- K Number
- K902171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5250
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia, Inc.
- Date Received
- May 14, 1990
- Decision Date
- October 5, 1990
- Product Code
- HDR
- 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 |
|---|---|---|---|
| HDR | Cap, Cervical | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDR), ordered by most recent decision date.
Béa Applicator (BAP-GB-01)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FERTI-LILY Conception Cup
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OVES CERVICAL CAP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMAGYN INTRAUTERINE INSEMINATION DEVICE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COOK INSEMINATION CUP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COAXIAL CATHETER SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Pharmacia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974350 | ALLERGAN IMMUNO CAP M4, M8, K70 | Feb 9, 1998 | Substantially Equivalent |
| K972364 | UNICAP PHADIATOP | Sep 4, 1997 | Substantially Equivalent |
| K972068 | UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 | Jul 3, 1997 | Substantially Equivalent |
| K970420 | MASTERCAP AM 5.0/MASTERCAP RM 5.0 | Jun 30, 1997 | Substantially Equivalent |
| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | Apr 23, 1997 | Substantially Equivalent |
| K962274 | UNICAP 100 | Sep 12, 1996 | Substantially Equivalent |
| K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA | Jan 30, 1996 | Substantially Equivalent |
| K954337 | GENOTROPIN MIXER | Nov 13, 1995 | Substantially Equivalent |
| K951025 | PISTON SYRINGE | Oct 19, 1995 | Substantially Equivalent |
| K952025 | ROBOCAP | Jul 26, 1995 | Substantially Equivalent |