Surg-Flex 10 Light
by Medical Products Development, Inc.
510(k) K803067
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK803067 | Date26 Feb 1981 | 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- Withdrawn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
- FSQ
- 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
The Surg-Flex 10 Light is a surgical instrument designed for use in general and plastic surgery procedures. Classified as a Class II device under FDA regulations (878.4580), it is intended for applications requiring precise handling and illumination during operative settings. Its construction and functionality align with traditional surgical tools, providing both mechanical support and enhanced visibility for the surgeon.
This device is supplied as a reusable instrument, intended for use in sterile surgical environments. It is regulated under the FDA’s 510(k) clearance process (K803067) and falls under the product code FSQ. No specific MRI safety information is provided, and its dimensions or additional technical specifications are not detailed in the regulatory records. Storage and handling should adhere to standard surgical instrument protocols to maintain sterility and functionality.
Other devices from Medical Products Development, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Surg-Flex 10 Light designed for?
The Surg-Flex 10 Light is a reusable surgical instrument specifically designed for use in general and plastic surgery procedures. Its primary purpose is to provide both mechanical support and enhanced visibility during operations, ensuring surgeons can perform precise tasks with improved illumination.
Is the Surg-Flex 10 Light single-use or reusable?
The Surg-Flex 10 Light is intended for reuse. It must be maintained in sterile conditions and handled according to standard surgical instrument protocols to preserve its functionality and sterility for repeated use in surgical settings.
What regulatory approval does the Surg-Flex 10 Light hold?
The Surg-Flex 10 Light is regulated under the FDA’s 510(k) clearance process, with clearance number K803067. It is classified as a Class II device under FDA regulations (878.4580) and is intended for applications requiring precise handling and illumination in surgical environments.
Are there any specific storage or handling instructions for the Surg-Flex 10 Light?
While the regulatory records do not specify unique storage instructions, standard surgical instrument protocols should be followed to maintain sterility and functionality. This includes proper cleaning, disinfection, and storage in a clean, dry environment to prevent contamination or damage.
Does the Surg-Flex 10 Light have any known limitations or special considerations?
The device is not explicitly stated to have MRI safety information, meaning its compatibility with MRI environments is not documented. Additionally, no technical specifications such as dimensions or additional features are detailed in the regulatory records, so users should rely on standard surgical practices for its application and care.