ApexM
510(k) K150183
ApexM is a Class II device made by Incontrol Medical, LLC, cleared under FDA 510(k) K150183 on 9 Apr 2015, 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 | NumberK150183 | Date9 Apr 2015 | StatusActive |
Official records
- FDA 510(k) database K150183
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPI
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5320
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K150183
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 | |||
|---|---|---|---|---|
| Apex®M 3100000A1 | 3100000A1 / 3100000A1 | 00851508007035 | Length 12 in | On the market |
| Apex®M by Viveve 3100000A4 | 3100000A4 / 3100000A4 | 00851508007097 | Length 12 in | On the market |
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