AMT Bridle - Nasal Tube Retention System— 510(k) K142971
Substantially EquivalentApplied Medical Technology, Inc.
FDA 510(k) clearance K142971 for AMT Bridle - Nasal Tube Retention System, Substantially Equivalent on 2015-05-26. Applicant: Applied Medical Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Technology, Inc.
- Product code
- Code KNT
- 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 KNT
view allMore clearances from Applied Medical Technology, Inc.
view allAdverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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 K142971
K-number listed on FDA's recall record- Z-1223-2017 — AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
- Z-1224-2017 — AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142971.
Data sourced from openFDA. This site is unofficial and independent of the FDA.