FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR
K Number: K964071
·
Decision Dec 12, 1996
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
24
Review Days
62
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Basic Information
- Device Name
- ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR
- K Number
- K964071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oratec Interventions, Inc.
- Date Received
- October 11, 1996
- Decision Date
- December 12, 1996
- 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 Oratec Interventions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013622 | NUCLEOTOMY INTRADISCAL CATHETER | Jan 31, 2002 | Substantially Equivalent |
| K003198 | VULCAN TAC PROBES, MODEL 911XXX | Aug 29, 2001 | Substantially Equivalent |
| K003893 | VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X | Mar 1, 2001 | Substantially Equivalent |
| K000691 | VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS | May 4, 2000 | Substantially Equivalent |
| K992805 | ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) | Feb 4, 2000 | Substantially Equivalent |
| K994333 | ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES | Jan 18, 2000 | Substantially Equivalent |
| K993967 | ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 | Dec 17, 1999 | Substantially Equivalent |
| K993854 | ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES | Dec 6, 1999 | Substantially Equivalent |
| K991140 | ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES | Oct 25, 1999 | Substantially Equivalent |
| K991218 | ORATEC BIPOLAR ABLATION PROBES | Sep 13, 1999 | Substantially Equivalent |