FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
K Number: K970077
·
Decision May 23, 1997
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
95
Applicant Total
38
Review Days
134
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Basic Information
- Device Name
- LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
- K Number
- K970077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5320
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Utah Medical Products, Inc.
- Date Received
- January 9, 1997
- Decision Date
- May 23, 1997
- Product Code
- KPI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Utah Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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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 |
| K955663 | ABC IN-LINE BLOOD SAMPLING KIT | Mar 17, 1997 | Substantially Equivalent |
| K964526 | LIBERTY RECTAL PELVIC FLOOR EXERCISER | Feb 10, 1997 | Substantially Equivalent |
| K961424 | INTRAN 500 | Jul 10, 1996 | Substantially Equivalent |