FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OMNIMED CLAMP
K Number: K851654
·
Decision May 31, 1985
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
13
Applicant Total
12
Review Days
39
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Basic Information
- Device Name
- OMNIMED CLAMP
- K Number
- K851654
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Omni Intl., Inc.
- Date Received
- April 22, 1985
- Decision Date
- May 31, 1985
- Product Code
- HXD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HXD | Clamp | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXD), ordered by most recent decision date.
KIDNEY CLAMP
FDA 510(k)
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INTESTINAL CLAMP
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FDA Class 1
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INTESTINAL CRUSHING CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PARAMETRIUM CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VASCULAR CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
C CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Omni Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K984066 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM | Jan 13, 1999 | Substantially Equivalent |
| K984064 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE | Jan 8, 1999 | Substantially Equivalent |
| K853255 | OMNIMED I.V. SOLUTION ADMIN. SET | Aug 23, 1985 | Substantially Equivalent |
| K851938 | OMNIMED SURGICAL GOWN | Jun 28, 1985 | Substantially Equivalent |
| K851734 | OMNIMED SUPERIOR TRANSDUCER PROTECTOR | May 23, 1985 | Substantially Equivalent |
| K850706 | F-SERIES IMPLANT | Apr 10, 1985 | Substantially Equivalent |
| K850112 | OMNIMED IV SOLUTION ADMINISTRATION SET | Feb 22, 1985 | Substantially Equivalent |
| K850066 | OMNIMED NASAL OXYGEN CANNULA | Jan 24, 1985 | Substantially Equivalent |
| K831147 | OMNIPROBE ELECTRICAL NERVE STIMULATOR | Jul 18, 1983 | Substantially Equivalent |
| K821523 | OMNI TENS | Jun 16, 1982 | Substantially Equivalent |