FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAN PLUS
K Number: K955443
·
Decision Feb 20, 1996
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
8
Applicant Total
38
Review Days
84
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Basic Information
- Device Name
- INTRAN PLUS
- K Number
- K955443
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2700
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Utah Medical Products, Inc.
- Date Received
- November 28, 1995
- Decision Date
- February 20, 1996
- Product Code
- HFN
- 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 |
|---|---|---|---|
| HFN | Transducer, Pressure, Intrauterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFN), ordered by most recent decision date.
Koala Intrauterine Pressure Catheter (IPC-5000E)
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KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
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PRE-FILLED SYRINGE FOR KOALA IUP
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INTRAN 500
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STORC INTRAUTERINE PRESSURE CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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|---|---|---|---|
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| 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 |