Uni-Tip Colostomy Irrigation Cone
FDA 510(k) K823274 · Howmedica Corp.
510(k) numberK823274
Submission
- Device name
- Uni-Tip Colostomy Irrigation Cone
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- November 3, 1982
- Decision date
- December 7, 1982
- 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 |
| 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 |
| K770251 | Super X AdjustretteEXD · Traditional | Qualitone | 02/28/1977SE |
More from Qualitone
| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Uni-Tip Colostomy Irrigation Cone cleared by the FDA?
Uni-Tip Colostomy Irrigation Cone (K823274) received a 510(k) decision of Substantially Equivalent on December 7, 1982, 34 days after the submission was received.
What is the product code of K823274?
The FDA product code is EXD – Irrigator, Ostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5895.