Sur-Fit Irrigation Sleeve
FDA 510(k) K811160 · E. R. Squibb & Sons, Inc.
510(k) numberK811160
Submission
- Device name
- Sur-Fit Irrigation Sleeve
- Applicant
- E. R. Squibb & Sons, Inc.
New York, NY, US - Received
- April 28, 1981
- Decision date
- June 2, 1981
- 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 |
| 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 |
|---|---|---|
| K821494 | Ria Stat 16JJJ · Traditional | 06/03/1982SE |
| K820616 | Angiotensis I-Squibb RadioimmunoassayCIB · Traditional | 03/26/1982SE |
| K820341 | Cortisol-Squibb Radioimmunoassay KitCGR · Traditional | 03/04/1982SE |
| K820340 | T3 Uptake-Squibb Diagnostic KitKHQ · Traditional | 03/04/1982SE |
| K811240 | Sur-Fit Loop Ostomy O.R. SetEXB · Traditional | 06/16/1981SE |
| K811239 | Sur-Fit Disposable Convex InsertEXB · Traditional | 06/09/1981SE |
| K811163 | Sur-Fit Disposable Fange CapEXB · Traditional | 05/21/1981SE |
| K810966 | Diagoxin Squibb Radioimmunoassay KitDNL · Traditional | 04/21/1981SE |
| K810211 | T3 Ria KitCDP · Traditional | 02/10/1981SE |
| K803100 | Stomahesive Paste Protective Skin BarrEZR · Traditional | 01/08/1981SE |
Questions and answers
When was Sur-Fit Irrigation Sleeve cleared by the FDA?
Sur-Fit Irrigation Sleeve (K811160) received a 510(k) decision of Substantially Equivalent on June 2, 1981, 35 days after the submission was received.
What is the product code of K811160?
The FDA product code is EXD – Irrigator, Ostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5895.