Mini ONE Enteral Extension Set— 510(k) K142989
Substantially EquivalentApplied Medical Technology, Inc.
FDA 510(k) clearance K142989 for Mini ONE Enteral Extension Set, Substantially Equivalent on 2015-01-29. Applicant: Applied Medical Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Technology, Inc.
- Product code
- Code PIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brecksville, OH, US
Recent devices under product code PIF
view allMore clearances from Applied Medical Technology, Inc.
view allAdverse events under product code PIF
product code PIF- Death
- 13
- Injury
- 122
- Other
- 1
- Total
- 136
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 K142989
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 K142989.
Data sourced from openFDA. This site is unofficial and independent of the FDA.