Disposable Light Handle and Adaptor
by Aspen Surgical Products, Inc.
510(k) K020304
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020304 | Date14 Feb 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FTA
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4580
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Light, Surgical, Accessory designed as a single-use, disposable component for surgical lighting systems. It serves as an interface between non-sterile operating room lamps and sterile surgical personnel, ensuring a sterile connection while maintaining illumination during procedures. Constructed from plastic, it is intended for use in general and plastic surgery settings to enhance sterility and reduce reprocessing requirements.
The Disposable Light Handle and Adapter is supplied sterile, intended for single-use only to minimize contamination risks. It is classified as a Class II device under FDA regulations and has received FDA 510K clearance as substantially equivalent to predicate devices. Available in various configurations (as referenced by multiple FEI numbers), it is designed for compatibility with standard surgical lighting systems and must be stored in a clean, dry environment prior to use. No MRI safety information is specified.
From the manufacturer
Flexible Light Handle Cover helps eliminate costly reprocessing and create uniformity throughout your hospital.
Manufacturer's product page: Conventional Handles
Other devices from Aspen Surgical Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Aspen Disposable Light Handle and Adapter used for?
The Aspen Disposable Light Handle and Adapter serves as a sterile interface between non-sterile operating room lamps and sterile surgical personnel. It maintains illumination during procedures while preventing contamination, making it ideal for general and plastic surgery settings. Its design eliminates the need for reprocessing, ensuring a clean and sterile connection.
How is the Disposable Light Handle and Adapter supplied, and what does this mean for its use?
The device is supplied sterile, which means it is pre-sterilized by the manufacturer and ready for immediate use without additional sterilization steps. This ensures a clean surgical environment and reduces the risk of contamination during procedures. Since it is intended for single-use only, each unit is designed to be discarded after one use to minimize contamination risks.
Is the Disposable Light Handle and Adapter reusable, and if not, why?
No, the Disposable Light Handle and Adapter is not reusable. It is explicitly designed for single-use to prevent cross-contamination between patients and to eliminate the need for reprocessing. Reusing single-use medical devices can introduce infection risks and compromise sterility, which is why this design prioritizes disposability.
What configurations or models are available for the Disposable Light Handle and Adapter?
The Disposable Light Handle and Adapter comes in multiple configurations, each identified by a unique FEI (Final Establishment Identification) number. These variations ensure compatibility with different standard surgical lighting systems. The exact FEI numbers listed include 1000208624, 3015542695, 3030516433, and others, allowing for flexibility in surgical setups.
How should the Disposable Light Handle and Adapter be stored before use?
The device must be stored in a clean, dry environment prior to use. Proper storage conditions help maintain its sterility and functionality. Avoid exposure to moisture, extreme temperatures, or contaminants, as these can compromise the integrity of the plastic material and the sterility of the device.