Aspisafe Gastric Tube
FDA 510(k) K961711 · B.Braun Medical, Inc.
510(k) numberK961711
Submission
- Device name
- Aspisafe Gastric Tube
- Applicant
- B.Braun Medical, Inc.
Bethlehem, PA, US - Received
- May 2, 1996
- Decision date
- June 11, 1997
- 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
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| 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 |
| 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 |
| K894870 | Wiltek Nasal Biliary Drainage SetBSS · Traditional | Wiltek Medical, Inc. | 12/21/1989SE |
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Questions and answers
When was Aspisafe Gastric Tube cleared by the FDA?
Aspisafe Gastric Tube (K961711) received a 510(k) decision of Substantially Equivalent on June 11, 1997, 405 days after the submission was received.
What is the product code of K961711?
The FDA product code is BSS – Tube, Nasogastric, a Class II (moderate risk) device regulated under 21 CFR 876.5980.