Enteral Feeding Spike Adapter
FDA 510(k) K072652 · Cedic S.R.L.
510(k) numberK072652
Submission
- Device name
- Enteral Feeding Spike Adapter
- Applicant
- Cedic S.R.L.
Peschiera Borromeo, IT - Received
- September 20, 2007
- Decision date
- January 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesPIF · Traditional | 04/25/2019SE |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus AdapterPIF · Traditional | 04/09/2019SE |
| K162254 | Cedic Enteral ENFit Transition ConnectorsPIO · Traditional | 05/04/2017SE |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortPIO · Traditional | 04/02/2015SE |
| K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…PIO · Traditional | 10/17/2014SE |
| K042129 | F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer LockFPA · Traditional | 01/27/2005SE |
Questions and answers
When was Enteral Feeding Spike Adapter cleared by the FDA?
Enteral Feeding Spike Adapter (K072652) received a 510(k) decision of Substantially Equivalent on January 18, 2008, 120 days after the submission was received.
What is the product code of K072652?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.