FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
K Number: K093256
·
Decision Nov 17, 2009
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
11
Review Days
29
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Basic Information
- Device Name
- SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
- K Number
- K093256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inrad
- Date Received
- October 19, 2009
- Decision Date
- November 17, 2009
- Product Code
- KNW
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Inrad
| K Number | Device Name | ||
|---|---|---|---|
| K093399 | PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 | Nov 19, 2009 | Substantially Equivalent |
| K090611 | REVOLUTION FULL CORE BIOPSY | Jun 4, 2009 | Substantially Equivalent |
| K063238 | ULTRACLIP II WING AND ULTRACLIP II COIL | Jan 30, 2007 | Substantially Equivalent |
| K042341 | ULTRACLIP II US | Sep 20, 2004 | 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 |