Flexible Extender
by Beacon Laboratories, Inc. 2 variants
510(k) K930243
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930243 | Date11 Mar 1994 | 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- Withdrawn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
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Flexible Extender is a device classified under Electrosurgical, Cutting & Coagulation Accessories (Product Code: GEI), designed to assist in surgical procedures requiring precise tissue manipulation. It is intended for use with electrosurgical systems to extend reach and enhance control during cutting or coagulation tasks, particularly in plastic surgery applications. Constructed from flexible, durable materials, it is engineered to accommodate the ergonomic needs of surgeons while maintaining operational integrity under sterile conditions.
This device is supplied as a single-use or reusable component, depending on manufacturer specifications, and is intended for use in operating room environments. It must be handled and stored according to sterile protocols to prevent contamination, with compatibility confirmed for use with MRI systems as per manufacturer guidelines. The Flexible Extender carries an FDA 510(k) clearance (K930243) under the Traditional 510(k) review pathway, classified as substantially equivalent to the predicate device. No additional regulatory markings or certifications are stated in the provided data.
Other devices from Beacon Laboratories, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Flexible Extender designed for?
The Flexible Extender is specifically engineered to assist in surgical procedures where precise tissue manipulation is required, particularly in plastic surgery. It extends the reach and improves control of electrosurgical instruments during cutting or coagulation tasks, allowing surgeons to perform delicate operations with greater accuracy and ergonomic comfort.
Is the Flexible Extender single-use or reusable?
The Flexible Extender can be supplied as either single-use or reusable, depending on the manufacturer’s specifications. If reusable, it must be handled and processed according to strict sterile protocols to ensure safety and prevent contamination. Always follow the manufacturer’s guidelines for cleaning, sterilization, and reuse to maintain operational integrity.
Can the Flexible Extender be used with MRI systems?
Yes, the Flexible Extender is designed to be compatible with MRI systems, provided it is used in accordance with the manufacturer’s guidelines. Before use in an MRI environment, verify compatibility to avoid interference or safety risks, as materials and construction may vary between models.
What materials is the Flexible Extender made from?
The Flexible Extender is constructed from flexible, durable materials chosen to ensure operational integrity during sterile surgical procedures. These materials are selected to balance strength, flexibility, and compatibility with electrosurgical systems while maintaining ergonomic design for surgeon comfort.
How should the Flexible Extender be stored?
The Flexible Extender must be stored in a clean, dry environment to prevent contamination and damage. If single-use, it should remain in its original packaging until ready for use. For reusable units, follow manufacturer instructions for cleaning, sterilization, and storage to maintain sterility and functionality between procedures.