FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
K Number: K080171
·
Decision Mar 6, 2008
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
14
Review Days
42
Basic Information
- Device Name
- SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
- K Number
- K080171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sanarus Medical, Inc.
- Date Received
- January 24, 2008
- Decision Date
- March 6, 2008
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNW), ordered by most recent decision date.
Promisemed VeriEcto Automatic Biopsy Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EnCor EnCompass Breast Biopsy and Tissue Removal System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Resitu Slider 09 (RESL09)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Forcyte Autograft Harvest Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Sanarus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K073533 | SANARUS V2 TREATMENT SYSTEM | Feb 7, 2008 | Substantially Equivalent |
| K062896 | V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 | Jan 3, 2007 | Substantially Equivalent |
| K061510 | SANARUS VISICA TREATMENT SYSTEM | Jul 18, 2006 | Substantially Equivalent |
| K052861 | MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 | Nov 15, 2005 | Substantially Equivalent |
| K051581 | SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 | Jul 27, 2005 | Substantially Equivalent |
| K042136 | SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM | Sep 8, 2004 | Substantially Equivalent |
| K032506 | SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM | Oct 9, 2003 | Substantially Equivalent |
| K020054 | SANARUS INDICA MARKER SYSTEM | Oct 16, 2002 | Substantially Equivalent |
| K022314 | SANARUS VISICA TREATMENT SYSTEM | Oct 15, 2002 | Substantially Equivalent |
| K022879 | MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY | Sep 23, 2002 | Substantially Equivalent |