FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
K Number: K983214
·
Decision Mar 27, 2000
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
36
Applicant Total
11
Review Days
560
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
- RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
- K Number
- K983214
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4400
- Medical Specialty
- Neurology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Rita Medical Systems
- Date Received
- September 14, 1998
- Decision Date
- March 27, 2000
- 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)
FDA 510(k)
FDA Class 2
·Neurology
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
FDA 510(k)
FDA Class 2
·Neurology
Racz Neurostat RF Generator
FDA 510(k)
FDA Class 2
·Neurology
OneRF Ablation System
FDA 510(k)
FDA Class 2
·Neurology
APEX 6
FDA 510(k)
FDA Class 2
·Neurology
Abbott Medical Grounding Pad, model RF-DGP-IS
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Rita Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K062935 | HABIB 4X LAPAROSCOPIC | Oct 13, 2006 | Substantially Equivalent |
| K040989 | RITA SYSTEMS | Apr 28, 2004 | Substantially Equivalent |
| K030967 | RITA STARBURST SDE ELECTROSURGICAL DEVICE | Apr 21, 2003 | Substantially Equivalent |
| K023846 | MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY | Dec 6, 2002 | Substantially Equivalent |
| K021329 | RITA SYSTEM | Oct 9, 2002 | Substantially Equivalent |
| K003676 | RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR | Apr 9, 2001 | Substantially Equivalent |
| K010060 | RITA STARBURST XLI ELECTROSURGICAL DEVICE | Jan 23, 2001 | Substantially Equivalent |
| K993944 | RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE | Dec 2, 1999 | Substantially Equivalent |
| K992693 | RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90 | Sep 10, 1999 | Substantially Equivalent |
| K983871 | RITA MODEL 70 ELECTROSURGICAL PROBE | Dec 1, 1998 | Substantially Equivalent |