CORTRAK* 2 Equilateral Enteral Access System
FDA 510(k) K191340 · Avanos Medical, Inc.
510(k) numberK191340
Submission
- Device name
- CORTRAK* 2 Equilateral Enteral Access System
- Applicant
- Avanos Medical, Inc.
Alpharetta, GA, US - Received
- May 20, 2019
- Decision date
- June 4, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
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| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | Avanos Medical, Inc. | 06/06/2024SE |
| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
More from Degania Silicone , Ltd.
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| K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg…IRP · Special | 01/31/2025SE |
| K241185 | CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional | 10/25/2024SE |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)GXD · Special | 08/14/2024SE |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | 06/06/2024SE |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS)KNT · Traditional | 04/22/2022SE |
| K203066 | COOLIEF Cooled Radiofrequency Kit AdvancedGXI · Traditional | 12/22/2020SE |
| K192491 | Coolief Radiofrequency Generator (CRG) SystemGXD · Traditional | 02/21/2020SE |
Questions and answers
When was CORTRAK* 2 Equilateral Enteral Access System cleared by the FDA?
CORTRAK* 2 Equilateral Enteral Access System (K191340) received a 510(k) decision of Substantially Equivalent on June 4, 2019, 15 days after the submission was received.
What is the product code of K191340?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.