FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
UMBICUT
K Number: K000227
·
Decision Apr 27, 2000
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
31
Review Days
94
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Basic Information
- Device Name
- UMBICUT
- K Number
- K000227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pollak (Intl.), Ltd.
- Date Received
- January 24, 2000
- Decision Date
- April 27, 2000
- Product Code
- HFW
- 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 |
|---|---|---|---|
| HFW | Clamp, Umbilical | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFW), ordered by most recent decision date.
JOEY CLAMP OPENING TOOL
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KAEN YIH UMBILICAL CORD CLAMP
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SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
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BUSSE UMBILICAL CORD CLAMP CUTTER
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DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
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FDA Class 2
·Obstetrics/Gynecology
KOALA CLAMP, KOALA CLAMP AND CUTTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Pollak (Intl.), Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K810049 | PEDICAT* | Apr 21, 1981 | Substantially Equivalent |
| K810050 | VECAFIX* | Mar 26, 1981 | Substantially Equivalent |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | Oct 31, 1980 | Substantially Equivalent |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | Oct 31, 1980 | Substantially Equivalent |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | Oct 10, 1980 | Substantially Equivalent |
| K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | Sep 26, 1980 | Substantially Equivalent |
| K801991 | PLASTIC FORCEPS CAT.#1001-1010 | Sep 16, 1980 | Substantially Equivalent |
| K801996 | GUAZE BANDAGES CAT.#101-169 | Sep 16, 1980 | Substantially Equivalent |
| K802021 | PEDIBAND CAT.#195-197 | Sep 16, 1980 | Substantially Equivalent |
| K802022 | STERILE GUAZE SWABS CAT.#301-420 | Sep 16, 1980 | Substantially Equivalent |