ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE— 510(k) K954439
Substantially EquivalentOratec Interventions, Inc.
FDA 510(k) clearance K954439 for ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE, Substantially Equivalent on 1995-12-18. Applicant: Oratec Interventions, Inc.. Device class: 2.
Clearance details
- Applicant
- Oratec Interventions, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code GEI
view allMore clearances from Oratec Interventions, Inc.
view all- K013622 — NUCLEOTOMY INTRADISCAL CATHETER
- K003198 — VULCAN TAC PROBES, MODEL 911XXX
- K003893 — VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X
- K000691 — VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS
- K992805 — ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.