MIDASystem™ IV-ASY-0450
MIDASystem™ IV-ASY-0450 is a Class II device made by Intravu, Inc., cleared under FDA 510(k) K181982 on 21 Aug 2018 and listed in FDA GUDID since 18 Jan 2019 (UDI-DI 00865351000310), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number00865351000310 | Date18 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181982 | Date21 Aug 2018 | StatusActive |
Official records
- AccessGUDID record 00865351000310
- FDA 510(k) database K181982
Across registries
- FDA 510(k) K181982 decided 21 Aug 2018 Active
- FDA GUDID UDI-DI 00865351000310 listed 18 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K181982
- Listed FDA GUDID 00865351000310
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MIDASystem™
- Generic name
- Endoscopic video image display unit
- Model / Ref / Catalog
- IV-ASY-0450
- Primary DI / UDI-DI
- 00865351000310
- 510(k) Number
- FDA product code
- GCJ, HRX
- GMDN term
- Endoscopic video image display unit
- Device class
- Class II
- Regulation number
- 876.1500, 888.1100
- GUDID distribution status
- Not in Commercial Distribution
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