FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HABIB 4X LAPAROSCOPIC
K Number: K062935
·
Decision Oct 13, 2006
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
11
Review Days
15
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
- HABIB 4X LAPAROSCOPIC
- K Number
- K062935
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rita Medical Systems
- Date Received
- September 28, 2006
- Decision Date
- October 13, 2006
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Rita Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |