CORTRAK* 2 Equilateral Enteral Access System— 510(k) K191340
Substantially EquivalentAvanos Medical, Inc.
FDA 510(k) clearance K191340 for CORTRAK* 2 Equilateral Enteral Access System, Substantially Equivalent on 2019-06-04. Applicant: Avanos Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Avanos Medical, 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
- Special
- Location
- Alpharetta, GA, US
Recent devices under product code KNT
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view all- K243572 — Game Ready system (550500-04) +11 more
- K241185 — CORGRIP* SR NG/NI Tube Retention System
- K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
- K240965 — CORTRAK* 2 Enteral Access System (20-0950)
- K220588 — Avanos* CORTRAK* 2 Enteral Access System (EAS)
Adverse 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 K191340
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 K191340.
Data sourced from openFDA. This site is unofficial and independent of the FDA.