TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018— 510(k) K002042
Substantially EquivalentNew England Medical Corp.
FDA 510(k) clearance K002042 for TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018, Substantially Equivalent on 2001-02-01. Applicant: New England Medical Corp.. Device class: 2.
Clearance details
- Applicant
- New England Medical Corp.
- Product code
- Code HGI
- Device class
- Class 2
- Regulation
- 21 CFR 884.4120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walden, NY, US
Recent devices under product code HGI
view allAdverse events under product code HGI
product code HGI- Other
- 1
- Total
- 1
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.