FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158— 510(k) K061651
Substantially EquivalentApple Medical Corp.
FDA 510(k) clearance K061651 for FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158, Substantially Equivalent on 2006-10-20. Applicant: Apple Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Apple 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
- Marlboro, MA, US
Recent devices under product code HGI
view allMore clearances from Apple Medical Corp.
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 →
Recalls naming K061651
K-number listed on FDA's recall record- Z-1612-2022 — Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
- Z-1879-2018 — Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061651.
Data sourced from openFDA. This site is unofficial and independent of the FDA.