FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
K Number: K974028
·
Decision Jan 21, 1998
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
9
Review Days
90
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Basic Information
- Device Name
- STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING
- K Number
- K974028
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conceptus, Inc.
- Date Received
- October 23, 1997
- Decision Date
- January 21, 1998
- Product Code
- MKO
- 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 |
|---|---|---|---|
| MKO | Falloposcope | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MKO), ordered by most recent decision date.
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IMAGYN FALLOPOSCOPY SYSTEM
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CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Conceptus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972210 | RESECTOSCOPE SAFETY SHEATH | Sep 5, 1997 | Substantially Equivalent |
| K962587 | CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM | Jan 31, 1997 | Substantially Equivalent |
| K954164 | HYSTEROSCOPE | Mar 12, 1996 | Substantially Equivalent |
| K953314 | CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM | Jul 28, 1995 | Substantially Equivalent |
| K932387 | CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL | Mar 6, 1995 | Substantially Equivalent |
| K932993 | INTRAUTERINE CATHETER AND INTRODUCER | Jan 6, 1995 | Substantially Equivalent |
| K933723 | CONCEPTUS UTERINE CATHETER | Dec 27, 1994 | Substantially Equivalent |
| K933981 | CERVICAL CATHETER | Dec 27, 1994 | Substantially Equivalent |