STRYKER RF ELECTRODES AND CANNULAE
FDA 510(k) clearance K032406 · decided 2004-04-01
Clearance details
- K-number
- K032406
- Device name
- STRYKER RF ELECTRODES AND CANNULAE
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 2003-08-04
- Decision date
- 2004-04-01
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- GXI
- Device class
- 2
- Regulation number
- 882.4725
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Instruments
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| This product is a single use sterile device that is used to direct the lesion to the targe recall (Z-2261-2024) | Stryker Corporation | 2024-07-03 |
| RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Produc recall (Z-2134-2012) | Stryker Instruments Div. of Stryker Corporation | 2012-08-02 |
| RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Produ recall (Z-2135-2012) | Stryker Instruments Div. of Stryker Corporation | 2012-08-02 |