SmartBag (SmartPouch)
FDA 510(k) K181643 · 11 Health Technologies Limited
510(k) numberK181643
Submission
- Device name
- SmartBag (SmartPouch)
- Applicant
- 11 Health Technologies Limited
Borehamwood, GB - Received
- June 22, 2018
- Decision date
- November 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EXB – Collector, Ostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | Coloplast Corp. | 10/06/2025SE |
| K140938 | Ostom-I AlertEXB · Traditional | 11 Health and Technologies, LLC | 10/10/2014SE |
| K922730 | Lake Ostomy Care SetEXB · Traditional | Lake Medical Products, Inc. | 12/30/1993SESK |
| K882878 | Odor-End Emergency Clean Up PowderEXB · Traditional | Cdc Products Corp. | 12/08/1988SE |
| K881636 | Conseal Colostomy Continence System (One-Piece)EXB · Traditional | Coloplast A/S | 07/13/1988SE |
| K880306 | Emergency-Clean Up(Tm) EcpEXB · Traditional | Cdc Products Corp. | 05/20/1988SE |
| K872294 | Combination Nite Drainage UnitEXB · Traditional | Arnold Technologies | 12/29/1987SE |
| K873929 | 'Catch-It' or Fecal Containment DeviceEXB · Traditional | Midwest Medical Co. | 12/03/1987SE |
| K871526 | Odor-Safe(Tm)(Liquid) Odor-Safe(Tm) PowderEXB · Traditional | Cox Family Laboratories, Inc. | 10/13/1987SE |
| K871738 | Osto-PureEXB · Traditional | Clearchem Corp. | 08/12/1987SE |
Questions and answers
When was SmartBag (SmartPouch) cleared by the FDA?
SmartBag (SmartPouch) (K181643) received a 510(k) decision of Substantially Equivalent on November 16, 2018, 147 days after the submission was received.
What is the product code of K181643?
The FDA product code is EXB – Collector, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.