Simplystrong, Simplyezee
510(k) K181791
Simplystrong, Simplyezee is a Class II device made by Genicon, Inc., cleared under FDA 510(k) K181791 on 21 Aug 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181791 | Date21 Aug 2018 | StatusActive |
Official records
- FDA 510(k) database K181791
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GCJ
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K181791
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Simply EZee 550-000-020 | 550-000-020 | 00877972007241 | — | On the market |
| Simply EZee 550-000-026 | 550-000-026 | 00877972007395 | — | On the market |
| Simply EZee 550-000-027 | 550-000-027 | 00877972007371 | — | On the market |
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