FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMIN
K Number: K943448
·
Decision Apr 11, 1995
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
38
Review Days
267
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Basic Information
- Device Name
- LUMIN
- K Number
- K943448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Utah Medical Products, Inc.
- Date Received
- July 18, 1994
- Decision Date
- April 11, 1995
- Product Code
- LKF
- 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKF), ordered by most recent decision date.
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FemVue MINI Saline-Air Device
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RELIEEV Uterine Manipulator Injector (CUMI 5.0)
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FemChec Controlled Saline-Air Device (FCD-250)
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Rejoni Intrauterine Catheter
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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 |