VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS— 510(k) K000691
Substantially EquivalentOratec Interventions, Inc.
FDA 510(k) clearance K000691 for VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS, Substantially Equivalent on 2000-05-04. Applicant: Oratec Interventions, Inc.. Device class: 2.
Clearance details
- Applicant
- Oratec Interventions, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code HRX
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- K003198 — VULCAN TAC PROBES, MODEL 911XXX
- K003893 — VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X
- K992805 — ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
- K994333 — ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.