FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL
K Number: K932387
·
Decision Mar 6, 1995
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
9
Review Days
658
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Basic Information
- Device Name
- CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL
- K Number
- K932387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Conceptus, Inc.
- Date Received
- May 17, 1993
- Decision Date
- March 6, 1995
- Product Code
- HET
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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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 |
| 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 |