FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEURO-PATCH
K Number: K960470
·
Decision May 10, 1996
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
41
Applicant Total
174
Review Days
99
Basic Information
- Device Name
- NEURO-PATCH
- K Number
- K960470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5910
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AESCULAP, INC.
- Date Received
- February 1, 1996
- Decision Date
- May 10, 1996
- Product Code
- GXQ
- 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 |
|---|---|---|---|
| GXQ | Dura Substitute | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXQ), ordered by most recent decision date.
Helios Dura Regeneration Matrix
FDA 510(k)
FDA Class 2
·Neurology
ArtiFascia
FDA 510(k)
FDA Class 2
·Neurology
SyntheCel Dura Repair
FDA 510(k)
FDA Class 2
·Neurology
XenoSure Dura Biologic Patch
FDA 510(k)
FDA Class 2
·Neurology
Cerafix Dura Substitute
FDA 510(k)
FDA Class 2
·Neurology
DuraGen Secure Dural Regeneration Matrix
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by AESCULAP, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K152960 | ELAN 4 Motor System | Jul 22, 2016 | Substantially Equivalent |
| K160393 | AdTec | May 26, 2016 | Substantially Equivalent |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Feb 17, 2016 | Substantially Equivalent |
| K151865 | PremiPatch PTFE Pledget | Oct 27, 2015 | Substantially Equivalent |
| K143729 | SterilContainer S | Aug 18, 2015 | Substantially Equivalent |
| K151696 | Caiman Seal and Cut Technology | Jul 20, 2015 | Substantially Equivalent |
| K142970 | SterilContainer S System | Jul 8, 2015 | Substantially Equivalent |
| K141687 | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM | Apr 2, 2015 | Substantially Equivalent |
| K142315 | MINOP Disposable Introducer 26F | Nov 14, 2014 | Substantially Equivalent |
| K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | Jul 15, 2014 | Substantially Equivalent |