Bloxom Irrigator
FDA 510(k) K871791 · I.B. Bloxom C/O Hogan & Hartson
510(k) numberK871791
Submission
- Device name
- Bloxom Irrigator
- Applicant
- I.B. Bloxom C/O Hogan & Hartson
Washington, D.C., DC, US - Received
- May 7, 1987
- Decision date
- May 20, 1987
- 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 |
| 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 |
| K770251 | Super X AdjustretteEXD · Traditional | Qualitone | 02/28/1977SE |
Questions and answers
When was Bloxom Irrigator cleared by the FDA?
Bloxom Irrigator (K871791) received a 510(k) decision of Substantially Equivalent on May 20, 1987, 13 days after the submission was received.
What is the product code of K871791?
The FDA product code is EXD – Irrigator, Ostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5895.