FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RITA STARBURST SDE ELECTROSURGICAL DEVICE
K Number: K030967
·
Decision Apr 21, 2003
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
11
Review Days
26
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Basic Information
- Device Name
- RITA STARBURST SDE ELECTROSURGICAL DEVICE
- K Number
- K030967
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rita Medical Systems
- Date Received
- March 26, 2003
- Decision Date
- April 21, 2003
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |
| K983214 | RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES | Mar 27, 2000 | Unknown |
| 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 |