Neomed Enteral Only Extension Set
FDA 510(k) K100288 · Neomed, Inc.
510(k) numberK100288
Submission
- Device name
- Neomed Enteral Only Extension Set
- Applicant
- Neomed, Inc.
Swanee, GA, US - Received
- February 1, 2010
- Decision date
- August 3, 2010
- 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 |
|---|---|---|
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…PNR · Traditional | 04/30/2019SE |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…PNR · Traditional | 06/17/2016SE |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsPNR · Traditional | 12/17/2015SE |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit ConnectorPNR · Traditional | 04/09/2015SE |
| K122373 | Neomed Oral/Enteral SyringeFMF · Special | 09/20/2012SE |
| K120182 | Neomed Gastrointestinal Tube and AccessoriesKNT · Traditional | 04/19/2012SE |
| K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO…FMF · Traditional | 03/10/2010SE |
| K082238 | Neomed Polyurethane Feeding TubeFPD · Special | 10/01/2008SE |
| K081515 | Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0FOS · Special | 07/21/2008SE |
| K073596 | Neomed Single Lumen Umbilical CatheterFOS · Traditional | 02/22/2008SE |
Questions and answers
When was Neomed Enteral Only Extension Set cleared by the FDA?
Neomed Enteral Only Extension Set (K100288) received a 510(k) decision of Substantially Equivalent on August 3, 2010, 183 days after the submission was received.
What is the product code of K100288?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.