Rebuilder(Tm)
510(k) K874085
Rebuilder(Tm) is a Class II device made by Micromed, Inc., cleared under FDA 510(k) K874085 on 11 Dec 1987, 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 | NumberK874085 | Date11 Dec 1987 | StatusActive |
Official records
- FDA 510(k) database K874085
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZJ
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K874085
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 | |||
|---|---|---|---|---|
| ReBuilder 2407 | 2407 | 00866650000308 | — | On the market |
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