HYSTERO CO2-PNEU 2221— 510(k) K964136
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K964136 for HYSTERO CO2-PNEU 2221, Substantially Equivalent on 1997-01-10. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code HIG
- Device class
- Class 2
- Regulation
- 21 CFR 884.1700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
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Adverse events under product code HIG
product code HIG- Death
- 8
- Other
- 2
- Total
- 10
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.