TROCAR ACCESS SHEATH— 510(k) K905471
Substantially EquivalentCook Ob/Gyn
FDA 510(k) clearance K905471 for TROCAR ACCESS SHEATH, Substantially Equivalent on 1991-05-09. Applicant: Cook Ob/Gyn. Device class: 2.
Clearance details
- Applicant
- Cook Ob/Gyn
- Product code
- Code HET
- Device class
- Class 2
- Regulation
- 21 CFR 884.1720
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Spencer, IN, US
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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.