Flexiflo Enteral Pump Set
FDA 510(k) K791531 · Abbott Laboratories
510(k) numberK791531
Submission
- Device name
- Flexiflo Enteral Pump Set
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 10, 1979
- Decision date
- September 12, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSS – Tube, Nasogastric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| 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 |
| K930510 | Radius Enteral Feeding TubeBSS · Traditional | Radius Intl., Inc. | 02/01/1995SE |
| 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 |
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Questions and answers
When was Flexiflo Enteral Pump Set cleared by the FDA?
Flexiflo Enteral Pump Set (K791531) received a 510(k) decision of Substantially Equivalent on September 12, 1979, 33 days after the submission was received.
What is the product code of K791531?
The FDA product code is BSS – Tube, Nasogastric, a Class II (moderate risk) device regulated under 21 CFR 876.5980.