Tri-Med Gastric Lavage System
FDA 510(k) K920619 · Tri-Med Specialties, Inc.
510(k) numberK920619
Submission
- Device name
- Tri-Med Gastric Lavage System
- Applicant
- Tri-Med Specialties, Inc.
Overland Park, KS, US - Received
- February 11, 1992
- Decision date
- September 4, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KDH – Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KDH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983624 | Giltech Plus Connecting Tube SetKDH · Traditional | Giltech Plus, Inc. | 03/18/1999SE |
| K981286 | Superflow Irrigation and Aspiration Tubing SetsKDH · Traditional | Armm, Inc. | 06/19/1998SE |
| K971259 | Combiport Fluid Lavage DeviceKDH · Traditional | B.Braun Medical, Inc. | 10/27/1997SE |
| K962850 | Tum-E-VacKDH · Traditional | Ethox Corp. | 02/21/1997SE |
| K951533 | Easi-Lav Pediatric / Adult Gastric Lavage KitKDH · Traditional | Ballard Medical Products | 07/05/1995SE |
| K923497 | Flushing Irrigation SetKDH · Traditional | Orion Life Systems, Inc. | 03/21/1994SESK |
| K920527 | Tri-Med Quick-Step Gastric Lavage KitKDH · Traditional | Tri-Med Specialties, Inc. | 09/04/1992SE |
| K914908 | Quicvage PlusKDH · Traditional | Autovage | 04/13/1992SESK |
| K914907 | QuicvageKDH · Traditional | Autovage | 01/24/1992SE |
| K911919 | Minivage(R)KDH · Traditional | Autovage | 07/26/1991SE |
More from Autovage
| 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 |
| K934348 | Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FRBSS · Traditional | 12/23/1994SE |
| 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 |
Questions and answers
When was Tri-Med Gastric Lavage System cleared by the FDA?
Tri-Med Gastric Lavage System (K920619) received a 510(k) decision of Substantially Equivalent on September 4, 1992, 206 days after the submission was received.
What is the product code of K920619?
The FDA product code is KDH – Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration, a Class II (moderate risk) device regulated under 21 CFR 876.5980.