FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
K Number: K990100
·
Decision Aug 2, 2000
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
5
Review Days
576
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Basic Information
- Device Name
- POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
- K Number
- K990100
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Te ME NA S.A.R.L.
- Date Received
- January 4, 1999
- Decision Date
- August 2, 2000
- Product Code
- GXZ
- 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 |
|---|---|---|---|
| GXZ | Electrode, Needle | FDA class 2 | Neurology |
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Other Clearances by Te ME NA S.A.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K990323 | TE ME NA POLYSTIM NERVE STIMILATOR | Sep 28, 2001 | Substantially Equivalent |
| K002405 | SPINAL EPIDURAL NEEDLES | Jun 1, 2001 | Substantially Equivalent |
| K991259 | TE ME NA EPIDURAL CATHETER | Feb 21, 2001 | Substantially Equivalent |
| K990020 | TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC | Jun 24, 1999 | Substantially Equivalent |