Elmed Incorporated 52745-404E
Elmed Incorporated 52745-404E is a Class II device made by Elmed Incorporated, cleared under FDA 510(k) K181173 on 22 Mar 2019 and listed in FDA GUDID since 23 Sep 2026 (UDI-DI 00198506095344), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00198506095344 | Date23 Sep 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181173 | Date22 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00198506095344
- FDA 510(k) database K181173
Across registries
- FDA 510(k) K181173 decided 22 Mar 2019 Active
- FDA GUDID UDI-DI 00198506095344 listed 23 Sep 2026 Listed
Timeline
- Cleared FDA 510(k) K181173
- Listed FDA GUDID 00198506095344
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Elmed Incorporated
- Generic name
- Laparoscopic surgical procedure kit, non-medicated, reusable
- Model / Ref / Catalog
- 52745-404E
- Primary DI / UDI-DI
- 00198506095344
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Laparoscopic surgical procedure kit, non-medicated, reusable
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization