MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M— 510(k) K973737
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K973737 for MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M, Substantially Equivalent on 1997-12-12. Applicant: Richard Wolf Medical Instruments Corp..
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code HET
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
Adverse events under product code HET
product code HET- Malfunction
- 10,504
- Total
- 10,504
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.