FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAUTERINE CATHETER AND INTRODUCER
K Number: K932993
·
Decision Jan 6, 1995
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
28
Applicant Total
9
Review Days
567
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Basic Information
- Device Name
- INTRAUTERINE CATHETER AND INTRODUCER
- K Number
- K932993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5250
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conceptus, Inc.
- Date Received
- June 18, 1993
- Decision Date
- January 6, 1995
- Product Code
- MFD
- 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 |
|---|---|---|---|
| MFD | Cannula, Intrauterine Insemination | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Conceptus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974028 | STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING | Jan 21, 1998 | Substantially Equivalent |
| 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 |
| K933723 | CONCEPTUS UTERINE CATHETER | Dec 27, 1994 | Substantially Equivalent |
| K933981 | CERVICAL CATHETER | Dec 27, 1994 | Substantially Equivalent |