TrabEx Pro
The TrabEx Pro is a sterile, single-use manual ophthalmic knife used during eye surgery. Its handpiece combines the manual instrument with irrigation and aspiration functions when connected…
The TrabEx Pro is a sterile, single-use manual ophthalmic knife used during eye surgery. Its handpiece combines the manual instrument with irrigation and aspiration functions when connected to an ophthalmic irrigation and aspiration system.
The connected system provides fluid delivery and removal while the procedure is performed. An incision-sealing sleeve forms part of the handpiece, supporting its use through the surgical incision. The knife remains manually operated rather than supplying powered cutting.
Listed Item
The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.
Fluid Connection
Irrigation and aspiration depend on the external ophthalmic system. The handpiece provides the operative fluid pathway and is disposed of after a single use.
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | Microsurgical Technology, Inc., United States |
|---|---|
| FDA product code | MRH |
| Device type | Pump, Infusion, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K213173 |
| Record published | 2022-09-22 |
| Record revised | 2023-11-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 600050-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Viscous Fluid Pack | Escalon Medical Corp | 2 |
| Streamline Surgical System | New World Medical, Inc. | 2 |
| Omni Surgical System | Sight Sciences, Inc. | 2 |
| Omni Surgical System (US) | Sight Sciences, Inc. | 1 |
| iPRIME | Glaukos Corporation | 1 |
| Omni Plus | Sight Sciences, Inc. | 1 |
| VIA360 Surgical System | New World Medical, Inc. | 1 |
| ViscoInjector | Nova EYE Inc. | 1 |
| VISCO(TM)360 Viscosurgical System | Sight Sciences, Inc. | 1 |
| Omni Edge Surgical System | Sight Sciences, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213173 | 2022-06-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.