VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X— 510(k) K003893
Substantially EquivalentOratec Interventions, Inc.
FDA 510(k) clearance K003893 for VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X, Substantially Equivalent on 2001-03-01. 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
view allMore clearances from Oratec Interventions, Inc.
view all- K013622 — NUCLEOTOMY INTRADISCAL CATHETER
- K003198 — VULCAN TAC PROBES, MODEL 911XXX
- K000691 — VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS
- 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.