Ethox Lavage Tube
FDA 510(k) K860599 · Ethox Corp.
510(k) numberK860599
Submission
- Device name
- Ethox Lavage Tube
- Applicant
- Ethox Corp.
Buffalo, NY, US - Received
- February 19, 1986
- Decision date
- March 11, 1986
- 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 |
|---|---|---|
| K040286 | Ethox Surgi-Cuf Adult Disposable Blood Pressure CuffsDXQ · Abbreviated | 03/15/2004SE |
| K031195 | Cuf-Cover (TM)DXQ · Traditional | 10/10/2003SE |
| K962850 | Tum-E-VacKDH · Traditional | 02/21/1997SE |
| K935633 | No-MesKNT · Traditional | 09/30/1994SE |
| K921946 | Tum-E-Vac Bite BlockJXL · Traditional | 12/09/1992SE |
| K885220 | Percutaneous Endoscopic Gastrostomy KitKNT · Traditional | 09/25/1989SEKD |
| K894927 | Surgi SqueezKZD · Traditional | 09/11/1989SE |
| K883977 | Surgi-Cuf Sterile/Non-Sterile DisposableDXQ · Traditional | 02/10/1989SE |
| K844988 | Ethox Neonatal Blood Pressure Cuff-Sterile/Dispos.DXQ · Traditional | 04/04/1985SE |
| K841512 | Ethox Relia-Flo 2001 Enteral FeedFRN · Traditional | 05/21/1984SE |
Questions and answers
When was Ethox Lavage Tube cleared by the FDA?
Ethox Lavage Tube (K860599) received a 510(k) decision of Substantially Equivalent on March 11, 1986, 20 days after the submission was received.
What is the product code of K860599?
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.