Zephyr

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K880534 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Bnos Microvent, Model Ac and Model Ao

  Class II

  FDA 510(k) K944397 Active Cleared 31 Jan 1995

• Intego

  Class I

  FDA 510(k) K910904 Active Cleared 15 Mar 1991

• Is the Zephyr designed for single-use or can it be reused between patients, and what does that mean for maintenance?

  The Zephyr is a reusable surgical retractor, meaning it is intended to be cleaned, sterilized, and reused for multiple procedures. Since it is designed for controlled surgical environments, proper cleaning and sterilization between uses are essential to ensure safety and functionality. This process helps prevent contamination and maintains the device’s performance for improved tissue exposure during general and plastic surgery.

• What types of surgical procedures is the Zephyr primarily intended to assist with, and how does it improve the surgical experience?

  The Zephyr is specifically designed for general and plastic surgery procedures, where it holds back tissue to provide better visualization of the surgical site. By maintaining exposure, it helps surgeons work more efficiently and effectively, reducing the need for constant manual retraction and minimizing potential tissue trauma during the procedure.

• How is the Zephyr regulated, and what does the FDA’s clearance decision mean for its use in clinical settings?

  The Zephyr is regulated under an FDA 510(k) clearance (K880534) with a decision labeled as *Substantially Equivalent*, meaning it has been determined to be at least as safe and effective as a legally marketed device that served as its predicate. This clearance confirms its compliance with FDA standards for surgical retractors used in controlled environments, ensuring it meets regulatory requirements for use in general and plastic surgery.

• What should clinicians consider when storing the Zephyr to ensure it remains ready for use?

  Since the Zephyr is reusable, it should be stored in a clean, dry environment to prevent damage or contamination before and after sterilization. Proper storage also helps maintain its structural integrity, ensuring it remains functional when needed for surgical exposure during procedures. Follow manufacturer guidelines for handling and storage to extend its lifespan and reliability.