Itrack Advance
Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2) Ophthalmic ViscoInjector
6manufacturers in China registered for this device type
2catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
Record
| Listed by | Nova EYE Inc., United States |
|---|---|
| FDA product code | HMX |
| Device type | Cannula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Manufacturer |
| 510(k) | K221872 |
| Record published | 2023-04-04 |
| Record revised | 2026-05-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 30 °C |
| Sizes | Catheter working length 45 mm; outer diameter 250 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| iTrack-ADS | Catheter Working Length 45 mm | In distribution |
| iTrack-ADS | Catheter Working Length 45 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 909 |
| Walcott Rx Products | Walcott Rx Product Inc | 663 |
| MR Phaco | Crestpoint Management Ltd. | 625 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 511 |
| Ambler Surgical | Ambler Surgical, LLC | 447 |
| Millennium | Avalign Technologies, Inc. | 270 |
| Ophthalmic Cannula | Katena Products, Inc. | 251 |
| Surgistar | Surgistar, Inc. | 179 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 137 |
| Walcott Rx Products | Psi/Eye-Ko, Inc. | 133 |
| Surgical Direct | Surgical Direct, Inc. | 127 |
| Visitec® | Beaver-Visitec International, Ltd | 124 |
Showing 12 of 1,064. All products under Cannula, Ophthalmic
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-01-11 | Class II | Process control | Sterility failure found in one of the units in the lot. | 90 units | 2018-10-02 |
| 2014-08-06 | Class II | Under Investigation by firm | One lot may not have been properly sealed, resulting in a non-sterile device. | 148 devices | 2014-10-28 |
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.