FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPID PROGEAMMER 3.0
K Number: K052374
·
Decision Nov 22, 2005
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
138
Applicant Total
25
Review Days
84
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Basic Information
- Device Name
- RAPID PROGEAMMER 3.0
- K Number
- K052374
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advanced Neuromodulation Systems
- Date Received
- August 30, 2005
- Decision Date
- November 22, 2005
- Product Code
- GZB
- 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 |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZB), ordered by most recent decision date.
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
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Other Clearances by Advanced Neuromodulation Systems
| K Number | Device Name | ||
|---|---|---|---|
| K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 | Dec 23, 2009 | Substantially Equivalent |
| K090907 | PENTA LEAD KITS, MODELS: 3227-3234 | Jun 2, 2009 | Substantially Equivalent |
| K081208 | CINCH ANCHOR, MODEL 1194 | Jul 18, 2008 | Substantially Equivalent |
| K072462 | WIDE SPACED QUATTRODE LEADS | Oct 11, 2007 | Substantially Equivalent |
| K070847 | TRIAL CABLE, 3009 | Apr 11, 2007 | Substantially Equivalent |
| K063080 | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS | Dec 12, 2006 | Substantially Equivalent |
| K053250 | ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT | Dec 15, 2005 | Substantially Equivalent |
| K052418 | AXXESS BUTTERFLY ANCHOR | Sep 26, 2005 | Substantially Equivalent |
| K050922 | ANS SCS ACCESSORY KIT | May 18, 2005 | Substantially Equivalent |
| K050633 | TRIAL CABLE RETENTION CLIP | Apr 21, 2005 | Substantially Equivalent |