Miya Hook

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K926530 ↗

FDA Product Code

KNA

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Endo Cervical Curette

  Class II

  FDA 510(k) K926532 Active Cleared 25 Feb 1994

• Micro Surgery Needle Holders

  Class II

  FDA 510(k) K930110 Active Cleared 24 Feb 1994

• Gomco Circumcision Clamp

  Class II

  FDA 510(k) K926535 Active Cleared 25 Feb 1994

• Roto Fit Biopsy Forceps

  Class I

  FDA 510(k) K926527 Active Cleared 25 Feb 1994

• Various Forceps

  Class II

  FDA 510(k) K930799 Active Cleared 24 Feb 1994

• Ovum Forceps

  Class II

  FDA 510(k) K926528 Active Cleared 24 Feb 1994

See all devices from Thomasville Medical Assoc. →

• What types of medical procedures is the Miya Hook designed for, and how does its specialized design benefit clinicians?

  The Miya Hook is specifically designed for obstetric and gynecological procedures, where precise manual manipulation is required. Its specialized design allows clinicians to perform delicate tasks with enhanced control, making it particularly useful in settings where accuracy is critical, such as during certain deliveries or gynecological examinations.

• Is the Miya Hook intended for single-use or reusable applications, and what does this mean for infection control?

  The Miya Hook is supplied as a reusable instrument, meaning it is intended to be sterilized and used multiple times under proper infection control protocols. Reusability requires adherence to strict cleaning and sterilization procedures to ensure patient safety between uses.

• What regulatory pathway was followed for FDA clearance of the Miya Hook, and which advisory committee reviewed it?

  The Miya Hook received FDA clearance through the Traditional 510(k) pathway, determined to be Substantially Equivalent (SESE) to a predicate device. Its review was conducted by the Obstetrics/Gynecology Advisory Committee (OB), ensuring its safety and effectiveness for specialized obstetric-gynecologic applications.

• Are there multiple sizes or models of the Miya Hook available, and how might a clinician determine the appropriate one for their procedure?

  The regulatory data lists multiple FEI numbers (e.g., 3005747797, 1825146) and registration numbers, which may correspond to different models or variants of the Miya Hook. While exact sizing details aren’t provided, clinicians should consult the manufacturer’s documentation or technical specifications to select the appropriate model based on procedural requirements.

• Does the Miya Hook come with any specific storage or handling instructions, particularly regarding its reusable nature?

  Since the Miya Hook is reusable, proper storage and handling are essential to maintain its integrity and sterility. While the regulatory data doesn’t specify storage conditions, reusable surgical instruments typically require cleaning, sterilization, and storage in a clean, dry environment to prevent contamination and damage. Always follow the manufacturer’s guidelines for optimal performance.