RIWO DRIVE GENERATOR— 510(k) K984304
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K984304 for RIWO DRIVE GENERATOR, Substantially Equivalent on 1999-08-12. 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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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 →
Recalls naming K984304
K-number listed on FDA's recall record- Z-0789-2016 — Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
- Z-0790-2016 — Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
- Z-0791-2016 — Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984304.
Data sourced from openFDA. This site is unofficial and independent of the FDA.