FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO TARGETING ELECTRODE
K Number: K033173
·
Decision Mar 24, 2004
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
57
Applicant Total
12
Review Days
175
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MICRO TARGETING ELECTRODE
- K Number
- K033173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FHC, Inc.
- Date Received
- October 1, 2003
- Decision Date
- March 24, 2004
- Product Code
- GZL
- 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 |
|---|---|---|---|
| GZL | Electrode, Depth | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZL), ordered by most recent decision date.
Wovyn Depth Electrode
FDA 510(k)
FDA Class 2
·Neurology
Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept
FDA 510(k)
FDA Class 2
·Neurology
Neuro Omega System; NeuroSmart System
FDA 510(k)
FDA Class 2
·Neurology
Anchor Bolts as Accessories to Depth Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Spencer Probe Depth Electrodes
FDA 510(k)
FDA Class 2
·Neurology
SENSOSEEG Depth Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by FHC, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231141 | STarFix Designer Software C0265 | Sep 8, 2023 | Substantially Equivalent |
| K200169 | VFS1 Bipolar Electrosurgical Generator | May 14, 2020 | Substantially Equivalent |
| K183123 | microTargeting Guideline 4000 5.0 System | Dec 20, 2018 | Substantially Equivalent |
| K121950 | MICROTARGETING XL STAR DRIVE SYSTEM | Jul 26, 2012 | Substantially Equivalent |
| K092192 | WAYPOINT STEREOTACTIC SYSTEM | Feb 12, 2010 | Substantially Equivalent |
| K092562 | MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS | Sep 18, 2009 | Substantially Equivalent |
| K071364 | MICROTARGETING GUIDELINE 4000 | Jul 25, 2007 | Substantially Equivalent |
| K011775 | MICRO TARGETING DRIVE SYSTEM | Aug 30, 2001 | Substantially Equivalent |
| K011992 | FHC MICROTARGETING DRIVE SYSTEM | Aug 14, 2001 | Substantially Equivalent |
| K003776 | MICROTARGETING DRIVE SYSTEM | Feb 23, 2001 | Substantially Equivalent |