Miya Hook

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K891045 ↗

FDA Product Code

KNA

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Scissors: Thorek, Jorgensen, Finochietto

  Class I

  FDA 510(k) K891203 Active Cleared 6 Apr 1989

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  FDA 510(k) K891049 Active Cleared 17 Mar 1989

• Rectal Specula - Chelsea-Eaton, Kelly, Mathieu

  Class I

  FDA 510(k) K892542 Active Cleared 9 May 1989

• Zsi Biopsy Forceps

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  FDA 510(k) K891027 Active Cleared 17 Mar 1989

• Dental Root Elevator

  Class II

  FDA 510(k) K892255 Active Cleared 1 May 1989

• Vaginal Retractors - Kristeller, Delee, Breisky

  Class I

  FDA 510(k) K891038 Active Cleared 17 Mar 1989

See all devices from Zinnanti Surgical Instruments, Inc. →

• What is the Miya Hook used for in surgical procedures?

  The Miya Hook is a specialized manual surgical instrument designed for obstetric-gynecologic procedures. Its curved hook shape allows for controlled traction and retraction of anatomical structures, particularly prolapsed vaginal vaults, during minimally invasive or open surgeries. This precise manipulation helps surgeons achieve better visibility and access during delicate procedures.

• Is the Miya Hook intended for single-use or reusable applications?

  The Miya Hook is supplied as a reusable instrument, intended for single-user applications within sterile surgical settings. It is designed to be cleaned, sterilized, and maintained between uses to ensure functionality and safety. Proper adherence to surgical instrument protocols is required for repeated use.

• Why is the Miya Hook not MRI-safe?

  The Miya Hook contains metallic components, which disqualify it from being MRI-safe. Metallic instruments can distort MRI images and pose risks to patients during MRI scans, so it is important to avoid using this device in MRI environments. Always verify compatibility with imaging modalities before use.

• What storage and maintenance protocols should be followed for the Miya Hook?

  The Miya Hook requires adherence to standard surgical instrument protocols for storage, including thorough cleaning, sterilization, and regular maintenance. Proper handling ensures functionality, safety, and longevity of the instrument for repeated use in surgical settings. Follow manufacturer guidelines for cleaning agents and sterilization methods.

• What regulatory clearance does the Miya Hook hold?

  The Miya Hook is authorized under FDA 510(k) clearance (K891045) and falls under device class II. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended use.