Radius Enteral Feeding Tube
FDA 510(k) K930510 · Radius Intl., Inc.
510(k) numberK930510
Submission
- Device name
- Radius Enteral Feeding Tube
- Applicant
- Radius Intl., Inc.
Grayslake, IL, US - Received
- February 1, 1993
- Decision date
- February 1, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSS – Tube, Nasogastric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code BSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142483 | TurboSEAL Nasogastric Aspiration TubeBSS · Traditional | Turboseal, L.P. | 12/19/2014SE |
| K051480 | Enteral Feeding TubeBSS · Traditional | Biosearch Medical Products, Inc. | 10/12/2005SE |
| K984629 | Moss Tubes, Inc. Nasal Tube - Mark IVBSS · Traditional | Moss Tubes, Inc. | 03/02/1999SE |
| K961711 | Aspisafe Gastric TubeBSS · Traditional | B.Braun Medical, Inc. | 06/11/1997SE |
| K933596 | Gastric, Catheter, Irrigation & AspirationBSS · Traditional | Polamedco, Inc. | 02/13/1995SE |
| K935688 | AN-10S Andersen Tube with StyletBSS · Traditional | H.W. Andersen Products, Inc. | 12/30/1994SE |
| K934348 | Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FRBSS · Traditional | Tri-Med Specialties, Inc. | 12/23/1994SE |
| K905573 | Xemex Enteral Nutrition Catheter Nasogas. Type aBSS · Traditional | Zeon Medical Corp. | 06/19/1991SE |
| K910479 | Argyle Polyurethane Salem Sump TubeBSS · Traditional | Sherwood Medical Co. | 04/19/1991SE |
| K894870 | Wiltek Nasal Biliary Drainage SetBSS · Traditional | Wiltek Medical, Inc. | 12/21/1989SE |
More from Wiltek Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972102 | Radius Push Over the Guide Wire Percutaneous Endoscopic Gastrostomy KitKNT · Traditional | 01/23/1998SE |
| K972025 | Radius Pull Percutaneous Endoscopic Gastrostomy KitKNT · Traditional | 01/23/1998SE |
| K971901 | Radius Low Profile Gastrostomy Tube KitKNT · Traditional | 01/22/1998SE |
| K951560 | Radius Manual Whwwlchairs (Cobra, Viper, Swing, Olympia, and Mobil Models)IOR · Traditional | 04/17/1995SE |
Questions and answers
When was Radius Enteral Feeding Tube cleared by the FDA?
Radius Enteral Feeding Tube (K930510) received a 510(k) decision of Substantially Equivalent on February 1, 1995, 730 days after the submission was received.
What is the product code of K930510?
The FDA product code is BSS – Tube, Nasogastric, a Class II (moderate risk) device regulated under 21 CFR 876.5980.