Crafon Arthroscopy Lines
FDA 510(k)Class II (US FDA 510(k))
by Gambro, Inc.
Identifiers
- 510(k) Number
- K830673 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Crafon Arthroscopy Lines are arthroscopic instruments designed for use within joints during arthroscopic procedures. These devices are intended to assist in visualizing and manipulating internal joint structures, facilitating diagnostic and surgical interventions in orthopedic applications.
Supplied as single-use or reusable accessories for arthroscopic systems, these lines are classified under product code HRX and were cleared via the Traditional 510(k) pathway in 1983. They are intended for use in sterile environments and comply with FDA regulatory requirements as a Class 2 Orthopedic device, with no third-party certification noted.
Frequently asked questions
What types of procedures are the Crafon Arthroscopy Lines intended to assist with during arthroscopy?
The Crafon Arthroscopy Lines are designed to help visualize and manipulate internal joint structures during arthroscopic procedures. They support both diagnostic evaluations and surgical interventions in orthopedic applications, such as knee, shoulder, or other joint surgeries where internal visualization is required.
Are the Crafon Arthroscopy Lines available in single-use or reusable options, and how should they be handled?
The Crafon Arthroscopy Lines are supplied as either single-use or reusable accessories for arthroscopic systems. Since they are intended for sterile environments, reusable versions must be properly cleaned, sterilized, and maintained according to manufacturer guidelines to ensure safety and functionality.
How were these devices cleared by the FDA, and what does that mean for their regulatory status?
The Crafon Arthroscopy Lines were cleared via the Traditional 510(k) pathway in 1983 under product code HRX, with a decision of 'Substantially Equivalent' to a predicate device. This means the FDA determined they meet the same regulatory requirements as a previously approved orthopedic arthroscopy accessory, classifying them as a Class 2 device.
What does the advisory committee classification of 'Orthopedic' indicate about these devices?
The advisory committee classification of 'Orthopedic' (OR) reflects that these devices were reviewed by the Orthopedic Devices Panel, which specializes in evaluating arthroscopic and joint-related instruments. This classification does not describe their clinical use but rather how their submission was processed by the FDA.
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: K830673 FDA 510 (k) - CRAFON ARTHROSCOPY LINES | Gambro, Inc., CRAFON ARTHROSCOPY LINES (K830673) — FDA 510 (k) | Innolitics, CRAFON ARTHROSCOPY LINES 510 (k) K830673 - 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 | K830673 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro, Inc.
Sources (1)
- FDA 510(k) K830673 24 fields · synced Sep 19, 2026