Hybrid Surgical Device
by Lca, Inc.
510(k) K924160
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924160 | Date23 Apr 1993 | 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- Withdrawn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
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Hybrid Surgical Device is a surgical instrument classified under product code GEX, intended for use in general and plastic surgery procedures. It combines mechanical and thermal technologies to facilitate precise tissue approximation, cutting, and sealing, reducing the need for multiple standalone devices. This design supports improved surgical efficiency and reduced operative time while maintaining hemostasis and tissue integrity.
This device is supplied as a reusable surgical instrument, as indicated by its FDA 510(k) clearance (K924160) under the Substantially Equivalent determination. It is intended for use in controlled surgical environments, such as operating rooms, and requires proper sterilization and maintenance per manufacturer guidelines. No specific MRI safety classification or single-use designation is stated in the regulatory data. Storage and handling must comply with standard surgical instrument protocols to ensure functionality and sterility.
Other devices from Lca, Inc.
Questions
AI-generated answers, 1 Oct 2026
What surgical procedures is the Hybrid Surgical Device designed for?
The Hybrid Surgical Device is intended for use in general and plastic surgery procedures. Its design integrates mechanical and thermal technologies to perform precise tissue approximation, cutting, and sealing—reducing the need for multiple standalone instruments. This helps improve surgical efficiency and maintain hemostasis during procedures.
Is the Hybrid Surgical Device single-use or reusable?
The Hybrid Surgical Device is classified as a reusable surgical instrument, as confirmed by its FDA 510(k) clearance (K924160) under the Substantially Equivalent determination. Reusability is supported by proper sterilization and maintenance protocols outlined by the manufacturer, ensuring functionality and safety for repeated use in controlled surgical environments.
What sterilization and storage requirements apply to this device?
Since the Hybrid Surgical Device is reusable, it must undergo sterilization and maintenance per manufacturer guidelines to preserve its performance and sterility. Storage and handling should follow standard surgical instrument protocols to prevent contamination or damage, ensuring it remains ready for use in operating rooms.
Does this device have any special MRI safety considerations?
The regulatory data for the Hybrid Surgical Device does not specify an MRI safety classification. Clinicians should verify compatibility with their facility’s MRI protocols before use, particularly if the device contains metallic components or if MRI imaging is planned post-procedure.
How does the Hybrid Surgical Device improve surgical workflow?
The device combines mechanical and thermal technologies to perform cutting, sealing, and tissue approximation in a single tool, reducing the need for multiple instruments. This consolidation streamlines workflow, minimizes operative time, and helps maintain hemostasis—enhancing efficiency without compromising surgical precision.