PERCUTANEOUS ENDOSCOPIC DISCECTOMY— 510(k) K960222
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K960222 for PERCUTANEOUS ENDOSCOPIC DISCECTOMY, Substantially Equivalent on 1996-03-08. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- 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
- Vernon Hills, IL, US
Recent devices under product code HRX
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- K090776 — MEGAPULSE LASER SYSTEM AND FIBERS
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.