INSIGHT, MODEL S980000— 510(k) K012232
Substantially EquivalentSandhill Scientific, Inc.
FDA 510(k) clearance K012232 for INSIGHT, MODEL S980000, Substantially Equivalent on 2002-06-07. Applicant: Sandhill Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Sandhill Scientific, Inc.
- Product code
- Code FFX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Recent devices under product code FFX
view allMore clearances from Sandhill Scientific, Inc.
view allAdverse events under product code FFX
product code FFX- 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 K012232
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012232.
Data sourced from openFDA. This site is unofficial and independent of the FDA.