Tube, Gastro-Enterostomy
FDA 510(k) K760810 · Sherwood Medical Industries
510(k) numberK760810
Submission
- Device name
- Tube, Gastro-Enterostomy
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- October 2, 1976
- Decision date
- February 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EXD – Irrigator, Ostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5895
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121833 | Ostomy Irrigation SetEXD · Special | Coloplast A/S | 07/16/2012SE |
| K914692 | Urinary Diversion Evacuating CatheterEXD · Traditional | Cook Urological, Inc. | 07/02/1992SE |
| K904586 | Palex Irrigation SetEXD · Traditional | Palex Intl. SA | 12/28/1990SE |
| K871791 | Bloxom IrrigatorEXD · Traditional | I.B. Bloxom C/O Hogan & Hartson | 05/20/1987SE |
| K840268 | Irrigation SystemEXD · Traditional | Coloplast A/S | 04/05/1984SE |
| K832299 | Visi-Flow IrrigatorEXD · Traditional | Convatec, A Division of E.R. Squibb & Sons | 08/26/1983SE |
| K823274 | Uni-Tip Colostomy Irrigation ConeEXD · Traditional | Howmedica Corp. | 12/07/1982SE |
| K811160 | Sur-Fit Irrigation SleeveEXD · Traditional | E. R. Squibb & Sons, Inc. | 06/02/1981SE |
| K790749 | Colostomy Enema DeviceEXD · Traditional | Vabar Corp. | 05/16/1979SE |
| K790750 | Colostomy Device W/ Pressure LidEXD · Traditional | Vabar Corp. | 05/14/1979SE |
More from Vabar Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K801070 | Sherwood Disposable Endometrial SamplesHHK · Traditional | 07/21/1980SE |
| K801071 | Lancer Glucose Rate Reagent KitCGA · Traditional | 05/23/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | 11/13/1979SE |
| K792013 | Lancer L-Ina Human Reference SerumJIX · Traditional | 11/13/1979SE |
| K782077 | Lancer Ice CubeJRM · Traditional | 04/03/1979SE |
| K790523 | Argyle Esophageal StethoscopeBZW · Traditional | 03/27/1979SE |
| K790196 | Monoject Arterial Blood Sampling DeviceCBT · Traditional | 03/13/1979SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | 03/12/1979SE |
| K781459 | Monoject Scale MagnifierHJY · Traditional | 10/24/1978SE |
| K781060 | Monoject Endosseous Dental ImplantDZE · Traditional | 08/14/1978SE |
Questions and answers
When was Tube, Gastro-Enterostomy cleared by the FDA?
Tube, Gastro-Enterostomy (K760810) received a 510(k) decision of Substantially Equivalent on February 28, 1977, 149 days after the submission was received.
What is the product code of K760810?
The FDA product code is EXD – Irrigator, Ostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5895.