Cobo Temporary Keratoprosthesis
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K895013 FDA 510(k)
- FDA Product Code
- MLP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.3400 FDA 510(k)
- Regulation Number
- 886.3400 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cobo Temporary Keratoprosthesis is a Temporary Implant, Surgical Use Keratoprosthesis (per FDA classification), designed as a truncated quartz cone for short-term ocular reconstruction. Its primary function is to restore corneal integrity in cases of severe corneal damage or failure, providing structural support while allowing for fluid or gas infusion via an integrated stainless steel handle. The device includes a superior groove for suture fixation to the eye, ensuring stability during implantation. Made of autoclavable quartz, it is intended for intraoperative use in ophthalmic procedures requiring temporary corneal reinforcement.
This device is supplied as a reusable, autoclavable instrument and is classified under FDA regulation 886.3400 as a Class II medical device, with clearance via 510(k) submission (K895013). The 6.5 mm contact diameter and 40.0 mm handle length (as referenced in SKU OCTK-6.5) are critical dimensions for surgical application. It is intended for use in controlled surgical settings, where sterility and precise handling are maintained. No MRI safety information is specified, and storage requires adherence to autoclave protocols to preserve its quartz and stainless steel components.
Frequently asked questions
What is the primary purpose of the Cobo Temporary Keratoprosthesis in surgical procedures, and how does it function during implantation?
The Cobo Temporary Keratoprosthesis is designed to restore corneal integrity in cases of severe corneal damage or failure by providing short-term structural support. Its truncated quartz cone shape allows for fluid or gas infusion, while the integrated stainless steel handle facilitates intraoperative handling. The superior groove ensures secure suture fixation to the eye, maintaining stability during the procedure.
Is the Cobo Temporary Keratoprosthesis intended for single-use or reusable applications, and what sterilization method should be used?
The device is explicitly labeled as reusable and must be sterilized via autoclaving, as it is made of autoclavable quartz and stainless steel. This ensures compatibility with standard surgical sterilization protocols while preserving its structural integrity for repeated use in controlled settings.
What are the key dimensions of the Cobo Temporary Keratoprosthesis, and how do they impact its surgical application?
The device features a 6.5 mm contact diameter and a 40.0 mm handle length, which are critical for precise placement and stability during corneal reconstruction. These specifications ensure proper alignment and fixation to the eye while allowing surgeons to manipulate the implant effectively during intraoperative use.
How should the Cobo Temporary Keratoprosthesis be stored to maintain its integrity and functionality?
Storage requires adherence to autoclave protocols to preserve the quartz and stainless steel components. Since it is reusable, it must be kept in a sterile, dry environment and processed through proper sterilization cycles before each use to prevent contamination and ensure reliability in surgical settings.
Does the Cobo Temporary Keratoprosthesis have any restrictions on use, such as compatibility with MRI or specific surgical environments?
The device does not specify MRI safety information, meaning its use in MRI environments is not endorsed or tested. It is intended exclusively for controlled surgical settings where sterility and precise handling are maintained, such as operating rooms with proper autoclave facilities.
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: Ocular Cobo Temporary Keratoprosthesis - ocularinc.com, PDF Ocular Cobo Temporary Keratoprosthesis, Ocular® Cobo temporary keratoprosthesis - Ambler Surgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K895013 | Class II | Active |
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Manufacturer
- Manufacturer
- Ocular Instruments, Inc.
Sources (1)
- FDA 510(k) K895013 24 fields · synced Sep 20, 2026