Super X Adjustrette
FDA 510(k) K770251 · Qualitone
510(k) numberK770251
Submission
- Device name
- Super X Adjustrette
- Applicant
- Qualitone
Mchenry, IL, US - Received
- February 9, 1977
- 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 |
|---|---|---|
| K961827 | In-The-EarESD · Traditional | 07/03/1996SE |
| K955466 | Dynameq-Ii OptionESD · Traditional | 02/13/1996SE |
| K955359 | Cyber III Option Um, UC312, UC10, UcicESD · Traditional | 12/19/1995SE |
| K953884 | ProphetEWO · Traditional | 10/27/1995SE |
| K941107 | The Canal (C.I.C.) Aka/Hidden EarESD · Traditional | 08/09/1994SE |
| K935348 | Odyssey Clinical AudiometerEWO · Traditional | 02/09/1994SE |
| K935289 | Pro Fit-Cyber II OptionESD · Traditional | 12/22/1993SE |
| K923006 | AS-90ESD · Traditional | 09/18/1993SE |
| K923007 | AT-2EWO · Traditional | 02/26/1993SE |
| K923986 | Cybernetic Option (Cyber I)ESD · Traditional | 09/10/1992SE |
Questions and answers
When was Super X Adjustrette cleared by the FDA?
Super X Adjustrette (K770251) received a 510(k) decision of Substantially Equivalent on February 28, 1977, 19 days after the submission was received.
What is the product code of K770251?
The FDA product code is EXD – Irrigator, Ostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5895.