14F X 24CM Ash SPLIT-CATH,14F X 28CM Ash Split-Cath, 14F X 32CM Ash Split-Cath, 14FX36CM Ash Split-Cath, 14F X 40CM Ash
FDA 510(k) K013162 · Medcomp
510(k) numberK013162
Submission
- Device name
- 14F X 24CM Ash SPLIT-CATH,14F X 28CM Ash Split-Cath, 14F X 32CM Ash Split-Cath, 14FX36CM Ash Split-Cath, 14F X 40CM Ash
- Applicant
- Medcomp
Harleysville, PA, US - Received
- September 21, 2001
- Decision date
- October 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | Boehringer Laboratories, LLC | 08/14/2026SE |
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
| K250389 | XNY Disposable Gastric Calibration TubeKNT · Traditional | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 04/10/2025SE |
| K243228 | Flexi-Seal AIR (with ENFit Connector)KNT · Traditional | Convatec | 03/28/2025SE |
| K242336 | hygh-tec Drainage IIKNT · Traditional | Amb Medtec | 01/17/2025SE |
| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
| K241169 | Entarik NI Feeding Tube SystemKNT · Traditional | Gravitas Medical, Inc. | 11/22/2024SE |
| K241185 | CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional | Avanos Medical, Inc. | 10/25/2024SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K130889 | Split Cath RGMSD · Traditional | 04/28/2014SESK |
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| K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccLJS · Traditional | 12/21/2010SE |
| K091954 | Micro-Stick SetDYB · Traditional | 01/08/2010SE |
| K092347 | Pro-Picc CTLJS · Special | 09/16/2009SE |
| K091953 | Pro-PiccLJS · Traditional | 09/16/2009SE |
| K090394 | Valved Tearway IntroducerDYB · Traditional | 09/01/2009SE |
| K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple LumenLJS · Traditional | 07/23/2009SE |
| K091466 | 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model VPI.9S20, VPI.9S50LJS · Special | 06/17/2009SE |
| K081775 | The Medcomp .010 Vascular GuidewiresDQX · Traditional | 03/25/2009SE |
Questions and answers
When was 14F X 24CM Ash SPLIT-CATH,14F X 28CM Ash Split-Cath, 14F X 32CM Ash Split-Cath, 14FX36CM Ash Split-Cath, 14F X 40CM Ash cleared by the FDA?
14F X 24CM Ash SPLIT-CATH,14F X 28CM Ash Split-Cath, 14F X 32CM Ash Split-Cath, 14FX36CM Ash Split-Cath, 14F X 40CM Ash (K013162) received a 510(k) decision of Substantially Equivalent on October 19, 2001, 28 days after the submission was received.
What is the product code of K013162?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.