FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IUC - INTRAUTERINE CATHETER
K Number: K862873
·
Decision Feb 26, 1987
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
25
Applicant Total
38
Review Days
211
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Basic Information
- Device Name
- IUC - INTRAUTERINE CATHETER
- K Number
- K862873
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2700
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Utah Medical Products, Inc.
- Date Received
- July 30, 1986
- Decision Date
- February 26, 1987
- 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)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EASY TRANS TIP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IUP - TIP TRANS, IUP - PROXI TRANS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Utah Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K143424 | UTAH CVX-RIPE | Aug 28, 2015 | Substantially Equivalent |
| K123310 | FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) | Jan 23, 2013 | Substantially Equivalent |
| K101535 | BT-CATH | Jan 11, 2011 | Substantially Equivalent |
| K063611 | SALINE/ CONTRAST MEDIA INFUSION CATHETER | May 23, 2007 | Substantially Equivalent |
| K001874 | PERIPHERALLY INSERTED CENTRAL CATHETER | Sep 25, 2000 | Substantially Equivalent |
| K000974 | FOWLER ENDOCURETTE, MODEL CUR-XXX | May 23, 2000 | Substantially Equivalent |
| K965245 | TBD | Jul 3, 1997 | Substantially Equivalent |
| K970077 | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) | May 23, 1997 | Substantially Equivalent |
| K955663 | ABC IN-LINE BLOOD SAMPLING KIT | Mar 17, 1997 | Substantially Equivalent |
| K964526 | LIBERTY RECTAL PELVIC FLOOR EXERCISER | Feb 10, 1997 | Substantially Equivalent |