TabletVu IV-ASY-2000
TabletVu IV-ASY-2000 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 15 Oct 2021 (UDI-DI 00865351000389), 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 | Number00865351000389 | Date15 Oct 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181982 | Date21 Aug 2018 | StatusActive |
Official records
- AccessGUDID record 00865351000389
- FDA 510(k) database K181982
Across registries
- FDA 510(k) K181982 decided 21 Aug 2018 Active
- FDA GUDID UDI-DI 00865351000389 listed 15 Oct 2021 Listed
Timeline
- Cleared FDA 510(k) K181982
- Listed FDA GUDID 00865351000389
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TabletVu
- Generic name
- Endoscopic video image display unit
- Model / Ref / Catalog
- IV-ASY-2000
- Primary DI / UDI-DI
- 00865351000389
- 510(k) Number
- FDA product code
- HRX, GCJ
- GMDN term
- Endoscopic video image display unit
- Device class
- Class II
- Regulation number
- 888.1100, 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HRX (Arthroscope).
- MODEL AR-6300 INFUSION PUMP by Arthrex, Inc.
- ARTHTOTEK PRECISION HAND INSTRUMENTATION by Biomet, Inc.
- REMA SHAVER BLADES by Rema Medizintechnik GmbH.
- VANGUARD REPROCESSED ARTHROSCOPIC BLADES by Vanguard Medical Concepts, Inc.
- AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE by Axiamed, Inc.
- MEDINAUT Plus Kyphoplasty System MPB2-T2MN2-10 by IMEDICOM CO., LTD.
- SHEPPERD CUTTING FORCEPS by Downs Surgical, Ltd.
- DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE by Dyonics, Inc.
- Reprocessed Shavers/Burs by Renovo, Inc.
- Kyphoplasty Balloon System by OK Medinet Korea Co., Ltd.