FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
NEUROLAC(R) NERVE GUIDE
K Number: K112267
·
Decision Oct 20, 2011
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
39
Applicant Total
9
Review Days
73
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Basic Information
- Device Name
- NEUROLAC(R) NERVE GUIDE
- K Number
- K112267
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polyganics B.V.,
- Date Received
- August 8, 2011
- Decision Date
- October 20, 2011
- Product Code
- JXI
- 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 |
|---|---|---|---|
| JXI | Cuff, Nerve | FDA class 2 | Neurology |
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Other Clearances by Polyganics B.V.,
| K Number | Device Name | ||
|---|---|---|---|
| K141816 | HEMOPORE | Oct 23, 2014 | Substantially Equivalent |
| K141423 | NASOPORE-FD | Aug 7, 2014 | Substantially Equivalent |
| K070715 | NASOPORE EAR | May 7, 2007 | Substantially Equivalent |
| K062540 | NASOPORE EAR, MODELS ND04, ND05 | Oct 18, 2006 | Substantially Equivalent |
| K052099 | NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ | Nov 21, 2005 | Substantially Equivalent |
| K050573 | NEUROLAC NERVE GUIDE | May 4, 2005 | Substantially Equivalent |
| K042811 | VIVOSORB SHEET, MODEL FS01 | Nov 8, 2004 | Substantially Equivalent |
| K032115 | NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 | Oct 10, 2003 | Substantially Equivalent |