Stomach, Gastro-Enterostomy
FDA 510(k) K902421 · Gainor Medical Europe, Ltd.
510(k) numberK902421
Submission
- Device name
- Stomach, Gastro-Enterostomy
- Applicant
- Gainor Medical Europe, Ltd.
Mcdonough, GA, US - Received
- May 31, 1990
- Decision date
- November 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K920619 | Tri-Med Gastric Lavage SystemKDH · Traditional | Tri-Med Specialties, Inc. | 09/04/1992SE |
| 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 |
More from Autovage
| 510(k) | Device | Decision |
|---|---|---|
| K926448 | I.V. Administration SetFPA · Traditional | 05/02/1994SE |
| K931828 | Carelet Safety LancetFMK · Traditional | 10/15/1993SE |
| K931827 | Cleanlet, Cleanlet XL & KidsFMK · Traditional | 09/13/1993SE |
| K922441 | Sureseal BandageKGX · Traditional | 08/10/1993SE |
| K913333 | I.V. Priming SetFPA · Traditional | 10/23/1991SE |
| K902422 | Needle, Aspiration & Injection, DisposableFMI · Traditional | 06/06/1991SE |
| K902420 | Catheter, Nasal, OxygenCAT · Traditional | 04/17/1991SE |
| K902564 | Needle, DialysisFIE · Traditional | 03/01/1991SE |
| K902426 | Hemodialysis System and AccessoryFJK · Traditional | 11/20/1990SE |
| K902416 | Surelite and Surelite XL Blood LancetFMK · Traditional | 08/01/1990SE |
Questions and answers
When was Stomach, Gastro-Enterostomy cleared by the FDA?
Stomach, Gastro-Enterostomy (K902421) received a 510(k) decision of Substantially Equivalent on November 20, 1990, 173 days after the submission was received.
What is the product code of K902421?
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.