Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FR
FDA 510(k) K934348 · Tri-Med Specialties, Inc.
510(k) numberK934348
Submission
- Device name
- Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FR
- Applicant
- Tri-Med Specialties, Inc.
Overland Park, KS, US - Received
- September 7, 1993
- Decision date
- December 23, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K971615 | Pattison Esophageal DilatorKNQ · Traditional | 07/24/1997SE |
| K970890 | #ES-32 Suction Catheter 32 Fr.KNT · Traditional | 05/23/1997SE |
| K970982 | T-Rx Retrieval ForcepsOCZ · Traditional | 05/09/1997SE |
| K942918 | Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional | 02/28/1995SE |
| K950574 | Needle/CannulaLRO · Traditional | 02/24/1995SEKD |
| K945160 | Paracentesis Needles/CannulasLRO · Traditional | 11/14/1994SE |
| K924549 | Tri-Med Quick-Step(Tm) Rectal TubeGBT · Traditional | 02/10/1994SE |
| K932015 | Tri-Med Inflatable Esophageal DilatorKNQ · Traditional | 02/03/1994SE |
| K932652 | Tri-Med Paracentesis TrayLRO · Traditional | 11/24/1993SEKD |
| K931201 | Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional | 09/28/1993SE |
Questions and answers
When was Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FR cleared by the FDA?
Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FR (K934348) received a 510(k) decision of Substantially Equivalent on December 23, 1994, 472 days after the submission was received.
What is the product code of K934348?
The FDA product code is BSS – Tube, Nasogastric, a Class II (moderate risk) device regulated under 21 CFR 876.5980.