Oratec Interventions, Inc.
Menlo Park, CA, US
Oratec Interventions, Inc. appears in FDA device records in Menlo Park, CA. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Oratec Interventions, Inc. between 1995 and 2002. The busiest year on record is 1999, with 8. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 4 |
| 1999 | 8 |
| 2000 | 3 |
| 2001 | 2 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K013622 | NUCLEOTOMY INTRADISCAL CATHETER | GEI | Substantially Equivalent | |
| K003198 | VULCAN TAC PROBES, MODEL 911XXX | HRX | Substantially Equivalent | |
| K003893 | VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X | HRX | Substantially Equivalent | |
| K000691 | VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS | HRX | Substantially Equivalent | |
| K992805 | ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) | GEI | Substantially Equivalent | |
| K994333 | ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES | GEI | Substantially Equivalent | |
| K993967 | ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 | GEI | Substantially Equivalent | |
| K993854 | ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES | GEI | Substantially Equivalent | |
| K991140 | ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES | GEI | Substantially Equivalent | |
| K991218 | ORATEC BIPOLAR ABLATION PROBES | GEI | Substantially Equivalent | |
| K992408 | ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES | GEI | Substantially Equivalent | |
| K991190 | DEFLECTABLE ELECTROSURGICAL PROBES | GEI | Substantially Equivalent | |
| K990859 | DEFLECTABLE TAC ELECTROTHERMAL PROBE | GEI | Substantially Equivalent | |
| K990474 | ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES | GEI | Substantially Equivalent | |
| K984185 | MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY | GEI | Substantially Equivalent | |
| K982971 | ORATEC TAC-C, MONOPOLAR CAUTERY PROBE | GEI | Substantially Equivalent | |
| K974464 | ORATEC SPINECATH INTRADISCAL CATHETER | GEI | Substantially Equivalent | |
| K972358 | ORATEC MODEL ENDOTAC PROBE | GEI | Substantially Equivalent | |
| K973158 | ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE | GEI | Substantially Equivalent | |
| K973159 | ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR | GEI | Substantially Equivalent | |
| K965007 | ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES | GEI | Substantially Equivalent | |
| K964071 | ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR | GEI | Substantially Equivalent | |
| K963157 | ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY) | GEI | Substantially Equivalent | |
| K954439 | ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain