Elmed 5-0536-265B
Elmed 5-0536-265B 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 18 Jan 2023 (UDI-DI 00842180146990), 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 | GUDID listing | Number00842180146990 | Date18 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181173 | Date22 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00842180146990
- FDA 510(k) database K181173
Across registries
- FDA 510(k) K181173 decided 22 Mar 2019 Active
- FDA GUDID UDI-DI 00842180146990 listed 18 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K181173
- Listed FDA GUDID 00842180146990
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Elmed
- Generic name
- Rigid endoscopic scissors, reusable
- Model / Ref / Catalog
- 5-0536-265B
- Primary DI / UDI-DI
- 00842180146990
- 510(k) Number
- FDA product code
- GCJ, GEI
- GMDN term
- Rigid endoscopic scissors, reusable
- Device class
- Class II
- Regulation number
- 876.1500, 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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