LeadConfirm
by Alpha Omega Engineering Corp. 8 variants
LeadConfirm (STR-000075-00) is a Class II device made by Alpha Omega Engineering Corp., cleared under FDA 510(k) K191739 on 2 Jan 2020 and listed in FDA GUDID since 4 Mar 2021 (UDI-DI 07290114060868), active as of 21 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 | Number07290114060868 | Date4 Mar 2021 | StatusListed |
| United States | FDA 510(k) | NumberK191739 | Date2 Jan 2020 | StatusActive |
Official records
- AccessGUDID record 07290114060868
- FDA 510(k) database K191739
Across registries
- FDA 510(k) K191739 decided 2 Jan 2020 Active
- FDA GUDID UDI-DI 07290114060868 listed 4 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K191739
- Listed FDA GUDID 07290114060868
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrical-only medical device connection cable, single-use
- Model / Ref / Catalog
- Sterile NeuroSmart/NeuroNav LeadConfirm M Adaptor, STR-000075-00
- Primary DI / UDI-DI
- 07290114060868
- 510(k) Number
- FDA product code
- GZL
- GMDN term
- Electrical-only medical device connection cable, single-use
- Device class
- Class II
- Regulation number
- 882.1330
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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