FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
K Number: K061865
·
Decision Jul 27, 2006
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
67
Applicant Total
71
Review Days
24
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Basic Information
- Device Name
- FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
- K Number
- K061865
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guidant Corp.
- Date Received
- July 3, 2006
- Decision Date
- July 27, 2006
- Product Code
- NEY
- 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 |
|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEY), ordered by most recent decision date.
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IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
FDA 510(k)
FDA Class 2
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Other Clearances by Guidant Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K061453 | HI-TORQUE WHISPER VIEW GUIDE WIRE | Jun 22, 2006 | Substantially Equivalent |
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| K042218 | ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM | Aug 31, 2004 | Substantially Equivalent |
| K033834 | OMNILINK .018 BILIARY STENT SYSTEM | Jan 2, 2004 | Unknown |
| K033393 | ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM | Nov 10, 2003 | Unknown |
| K031678 | HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | Aug 26, 2003 | Substantially Equivalent |
| K031459 | RAPIDO CUT-AWAY CUTTER | Jul 23, 2003 | Substantially Equivalent |
| K031398 | IS-1 HEMOSTASIS VALVE, MODEL 6799 | May 20, 2003 | Substantially Equivalent |
| K030512 | GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM | May 14, 2003 | Substantially Equivalent |
| K030019 | MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE | Jan 24, 2003 | Substantially Equivalent |