FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRACLIP II US
K Number: K042341
·
Decision Sep 20, 2004
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
109
Applicant Total
11
Review Days
21
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Basic Information
- Device Name
- ULTRACLIP II US
- K Number
- K042341
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Inrad
- Date Received
- August 30, 2004
- Decision Date
- September 20, 2004
- Product Code
- NEU
- 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 |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Inrad
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|---|---|---|---|
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| K063238 | ULTRACLIP II WING AND ULTRACLIP II COIL | Jan 30, 2007 | Substantially Equivalent |
| K041201 | ULTRACLIP II MR | Jun 3, 2004 | Substantially Equivalent |
| K000612 | ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE | Apr 24, 2000 | Substantially Equivalent |
| K993785 | ULTRACLIP TISSUE MARKER | Feb 4, 2000 | Substantially Equivalent |
| K981721 | C0-AXIAL INTRODUCER NEEDLE | Jul 28, 1998 | Substantially Equivalent |
| K981166 | ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 | Jun 22, 1998 | Substantially Equivalent |
| K980587 | IV DECANTER-FLEXIBLE | Apr 17, 1998 | Substantially Equivalent |