Gastric, Catheter, Irrigation & Aspiration
FDA 510(k) K933596 · Polamedco, Inc.
510(k) numberK933596
Submission
- Device name
- Gastric, Catheter, Irrigation & Aspiration
- Applicant
- Polamedco, Inc.
Inglewood, CA, US - Received
- July 26, 1993
- Decision date
- February 13, 1995
- 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
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 |
| 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 |
More from Wiltek Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983000 | Cricothyrotomy TubeBTO · Traditional | 10/27/1999SE |
| K954383 | Sureloc Circuit ConnectorBZA · Traditional | 12/22/1995SE |
| K953793 | IntroscopeBZT · Traditional | 11/29/1995SE |
| K950713 | Airguide StyletteBSR · Traditional | 05/17/1995SE |
| K950380 | Flextitip StyletteBSR · Traditional | 02/10/1995SE |
| K920900 | Polamedco Tracheal and Nasotracheal TubesBTR · Traditional | 03/18/1992SE |
| K900456 | Polamedco Nasopaharyngeal AirwayBTQ · Traditional | 04/19/1990SE |
| K900457 | Cuffed Linder Nasotracheal AirwayBTR · Traditional | 04/16/1990SE |
| K894516 | Visoshield(Tm), Surgical Eye ProtectorFXX · Traditional | 09/12/1989SE |
| K881496 | Linder Nasotracheal AirwayBTR · Traditional | 05/31/1988SE |
Questions and answers
When was Gastric, Catheter, Irrigation & Aspiration cleared by the FDA?
Gastric, Catheter, Irrigation & Aspiration (K933596) received a 510(k) decision of Substantially Equivalent on February 13, 1995, 567 days after the submission was received.
What is the product code of K933596?
The FDA product code is BSS – Tube, Nasogastric, a Class II (moderate risk) device regulated under 21 CFR 876.5980.