Econolith EM1000
510(k) K063504
Econolith EM1000 is a Class II device made by Medispec, Ltd., cleared under FDA 510(k) K063504 on 9 Mar 2007, active as of 11 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 | NumberK063504 | Date9 Mar 2007 | StatusActive |
Official records
- FDA 510(k) database K063504
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LNS
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5990
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K063504
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 | |||
|---|---|---|---|---|
| Econolith EM1000 SW-8-A999d | SW-8-A999d | 07290016498363 | — | On the market |
| Econolith EM1000 SW-8-A999m | SW-8-A999m | 07290016498370 | — | On the market |
| Econolith EM1000 SW-8-A999q | SW-8-A999q | 07290016498387 | — | On the market |
| Econolith EM1000 SW-8-A999r | SW-8-A999r | 07290016498394 | — | On the market |
| Econolith EM1000 SW-8A999b | SW-8A999b | 07290016498356 | — | On the market |