AbbVie PEG— 510(k) K142793
UnknownAbbVie , Inc.
FDA 510(k) clearance K142793 for AbbVie PEG, Unknown on 2015-01-14. Applicant: AbbVie , Inc.. Device class: 2.
Clearance details
- Applicant
- AbbVie , Inc.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- North Chicago, IL, US
Recent devices under product code KNT
view allMore clearances from AbbVie , 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 K142793
K-number listed on FDA's recall record- Z-2176-2017 — AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
- Z-2177-2017 — AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
- Z-2178-2017 — AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
- Z-0786-2017 — AbbVie PEG Kit 20 FR
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142793.
Data sourced from openFDA. This site is unofficial and independent of the FDA.