FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
K Number: K974730
·
Decision Jul 14, 1998
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
25
Applicant Total
55
Review Days
208
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Basic Information
- Device Name
- SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
- K Number
- K974730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2700
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Graphic Controls Corp.
- Date Received
- December 18, 1997
- Decision Date
- July 14, 1998
- Product Code
- KXO
- 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 |
|---|---|---|---|
| KXO | Monitor, Pressure, Intrauterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXO), ordered by most recent decision date.
SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
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EASY TRANS TIP
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SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
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IUP - TIP TRANS, IUP - PROXI TRANS
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·Obstetrics/Gynecology
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
FDA 510(k)
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·Obstetrics/Gynecology
LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Graphic Controls Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981964 | MEDI-TRACE 4103 NEONATAL ELECTRODE | Nov 13, 1998 | Substantially Equivalent |
| K983287 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | Nov 5, 1998 | Substantially Equivalent |
| K980857 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE | May 12, 1998 | Substantially Equivalent |
| K972970 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | Aug 27, 1997 | Substantially Equivalent |
| K964387 | POINT OF USE II SHARPS-A-GATOR | Mar 27, 1997 | Substantially Equivalent |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | Jan 22, 1997 | Substantially Equivalent |
| K963151 | MEDI-TRACE 5700 RESTING ECG ELECTRODE | Nov 19, 1996 | Substantially Equivalent |
| K963038 | MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE | Nov 15, 1996 | Substantially Equivalent |
| K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 | Oct 28, 1996 | Substantially Equivalent |
| K955882 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS | Oct 24, 1996 | Substantially Equivalent |