Conphar Silicone Feeding Tube
FDA 510(k) K821825 · Conphar, Inc.
510(k) numberK821825
Submission
- Device name
- Conphar Silicone Feeding Tube
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- June 22, 1982
- Decision date
- August 10, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K821354 | Conphar Mayo Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821295 | Olsen Hegar Needle HoldersGDF · Traditional | 06/03/1982SE |
| K821289 | Mayo-Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | 05/28/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | 05/28/1982SE |
| K821286 | Iris Scissors Straight 4 1/2HNF · Traditional | 05/28/1982SE |
| K821285 | Splinter Forceps 4 1/2EFL · Traditional | 05/28/1982SE |
Questions and answers
When was Conphar Silicone Feeding Tube cleared by the FDA?
Conphar Silicone Feeding Tube (K821825) received a 510(k) decision of Substantially Equivalent on August 10, 1982, 49 days after the submission was received.
What is the product code of K821825?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.