FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANSPACH DISSECTION TOOLS
K Number: K113476
·
Decision Dec 16, 2011
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
60
Applicant Total
57
Review Days
24
Basic Information
- Device Name
- ANSPACH DISSECTION TOOLS
- K Number
- K113476
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- THE ANSPACH EFFORT, INC.
- Date Received
- November 22, 2011
- Decision Date
- December 16, 2011
- Product Code
- HBE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBE), ordered by most recent decision date.
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)
FDA 510(k)
FDA Class 2
·Neurology
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
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iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R
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2.1 x 255mm Drill, 22mm Stop
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| K Number | Device Name | ||
|---|---|---|---|
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | Jan 10, 2014 | Substantially Equivalent |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | Dec 31, 2013 | Substantially Equivalent |
| K082637 | CRANIAL PERFORATOR | Dec 22, 2008 | Substantially Equivalent |
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | Apr 30, 2008 | Substantially Equivalent |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | Jan 26, 2007 | Substantially Equivalent |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | Jan 16, 2007 | Substantially Equivalent |
| K052572 | ANSPACH KNOTLESS ANCHOR | Dec 5, 2005 | Substantially Equivalent |
| K050628 | ANSPACH COUPLER | Apr 7, 2005 | Substantially Equivalent |
| K042783 | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM | Dec 17, 2004 | Substantially Equivalent |
| K040186 | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM | Apr 15, 2004 | Substantially Equivalent |