FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
K Number: K071482
·
Decision Dec 20, 2007
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
36
Applicant Total
16
Review Days
204
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Basic Information
- Device Name
- STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
- K Number
- K071482
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synergetics, Inc.
- Date Received
- May 30, 2007
- Decision Date
- December 20, 2007
- Product Code
- GXD
- 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 |
|---|---|---|---|
| GXD | Generator, Lesion, Radiofrequency | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXD), ordered by most recent decision date.
GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
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Other Clearances by Synergetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121426 | AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS | Jul 10, 2012 | Substantially Equivalent |
| K121675 | VERSAVIT | Jun 21, 2012 | Substantially Equivalent |
| K113857 | SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE | Apr 23, 2012 | Substantially Equivalent |
| K110924 | DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS | Dec 7, 2011 | Substantially Equivalent |
| K091441 | SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET | Oct 30, 2009 | Substantially Equivalent |
| K063489 | STRYKER INTRADISCAL RF GENERATOR | May 23, 2007 | Substantially Equivalent |
| K032598 | SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE | Nov 24, 2003 | Substantially Equivalent |
| K020220 | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE | Aug 23, 2002 | Substantially Equivalent |
| K010637 | SONOTOME ULTRASONIC ASPIRATOR TIPS | Apr 20, 2001 | Substantially Equivalent |
| K990568 | SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 | May 14, 1999 | Substantially Equivalent |