Rectal Irrigation Tube
FDA 510(k) K841289 · Hdc Corp.
510(k) numberK841289
Submission
- Device name
- Rectal Irrigation Tube
- Applicant
- Hdc Corp.
Mchenry, IL, US - Received
- March 28, 1984
- Decision date
- July 6, 1984
- 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 |
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| K010425 | Epidural Catheter with Connector (and Accessory)KNF · Special | 03/15/2001SE |
| K994059 | Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07CAZ · Traditional | 10/13/2000SE |
| K002770 | Ibis Chemo-Port Implantable Vascular Access System, Model…LJT · Special | 09/26/2000SE |
| K983119 | Entero-Test HP, Model #102-01LIO · Traditional | 03/15/1999SE |
Questions and answers
When was Rectal Irrigation Tube cleared by the FDA?
Rectal Irrigation Tube (K841289) received a 510(k) decision of Substantially Equivalent on July 6, 1984, 100 days after the submission was received.
What is the product code of K841289?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.