Identifiers
- 510(k) Number
- K213173 FDA 510(k)
- FDA Product Code
- MRH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TrabEx Pro 600050-01 is an ophthalmic pump and infusion device designed for trabecular meshwork excision. Classified as a pump, infusion, and ophthalmic device, it is engineered to assist in procedures requiring precise tissue removal within the anterior chamber of the eye. Its design incorporates a serrated blade and trapezoidal configuration to facilitate controlled excision of the trabecular meshwork, aiding in glaucoma management by exposing collector channels.
This device is supplied as a single-use, sterile manual ophthalmic knife, intended for use in general hospital settings. It adheres to FDA 510(k) clearance under Traditional review (K213173) and falls under device class II (MRH product code). The TrabEx Pro 600050-01 is regulated under FDA regulation number 880.5725 and is intended for ophthalmic surgical applications. Storage and handling must comply with sterile instrument protocols to maintain integrity for clinical use.
Frequently asked questions
What is the TrabEx Pro 600050-01 used for in ophthalmic surgery?
The TrabEx Pro 600050-01 is specifically designed for trabecular meshwork excision, a procedure used in glaucoma management. It facilitates controlled removal of trabecular tissue in the anterior chamber of the eye, exposing collector channels to improve aqueous humor drainage. This helps manage intraocular pressure, a key factor in glaucoma treatment.
How is the TrabEx Pro 600050-01 supplied and what are its sterility and reuse guidelines?
The TrabEx Pro 600050-01 is supplied as a single-use, sterile manual ophthalmic knife. Due to its sterile packaging and intended use, it is not designed for reuse. Clinicians must adhere to sterile instrument protocols during storage and handling to ensure device integrity before use in surgical settings.
What distinguishes the TrabEx Pro 600050-01 from other ophthalmic pumps?
The TrabEx Pro 600050-01 features a serrated blade and trapezoidal configuration, which are engineered to provide precise and controlled excision of the trabecular meshwork. This design minimizes trauma to surrounding tissues while effectively exposing collector channels, making it particularly suited for trabecular meshwork procedures in glaucoma surgery.
Where should the TrabEx Pro 600050-01 be stored, and what are the regulatory requirements?
The TrabEx Pro 600050-01 must be stored in accordance with sterile instrument protocols to maintain its integrity for clinical use. It is regulated under FDA regulation number 880.5725 and has received FDA 510(k) clearance under Traditional review (K213173). Storage conditions should ensure the device remains uncontaminated and ready for single-use in general hospital settings.
Is the TrabEx Pro 600050-01 approved for use in all types of ophthalmic procedures?
No, the TrabEx Pro 600050-01 is specifically intended for trabecular meshwork excision procedures related to glaucoma management. While it is classified as a pump, infusion, and ophthalmic device, its design and FDA clearance (K213173) are tailored for controlled tissue removal in the anterior chamber of the eye, not for general ophthalmic surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TrabEx Pro - MST store - MicroSurgical, TrabEx - MST store - MicroSurgical, TrabEx Pro 600050-01 The MicroSurgical Technology… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213173 | Class II | Active |
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Manufacturer
- Manufacturer
- Microsurgical Technologies, Inc.
Sources (1)
- FDA 510(k) K213173 24 fields · synced Oct 1, 2026