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IOGYN Endoscope

by Iogyn, Inc.

510(k) K123330

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123330 Date19 Mar 2013ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HIH
Device Class
Class II
Regulation
21 CFR Part 884.1690
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IOGYN Endoscope is a rigid, multi-channel hysteroscope designed for visualization and access during gynecological procedures. It incorporates a rod-lens optical system for high-quality image transmission and is intended for use in diagnostic and operative hysteroscopy, enabling internal uterine examination and intervention.

This device is supplied as part of a system requiring compatible light sources, irrigation solutions (e.g., USP saline), and endoscopic accessories. It is classified as a Class II medical device under FDA regulation 884.1690 and has received FDA 510(k) clearance (K123330). The endoscope is intended for single-use or reusable applications, depending on manufacturer guidelines, and must be handled in accordance with sterile procedures when used clinically.

Other devices from Iogyn, Inc.

  • Iogyn System

    Class II

  • Iogyn System

    Class II

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the IOGYN Endoscope used for in gynecological procedures?

    The IOGYN Endoscope is designed for visualization and access during diagnostic and operative hysteroscopy. It enables internal uterine examination and intervention, allowing clinicians to perform procedures such as biopsies, polyp removal, or uterine cavity assessment with high-quality image transmission via its rod-lens optical system.

  • How is the IOGYN Endoscope supplied, and what accessories are required?

    The IOGYN Endoscope is part of a system that requires compatible light sources and irrigation solutions, such as USP saline. It is not sold as a standalone device, so clinicians must ensure they have the full set of accessories for proper functionality and sterile use.

  • Is the IOGYN Endoscope single-use or reusable, and how should it be handled?

    The IOGYN Endoscope can be used either as a single-use or reusable device, depending on the manufacturer’s guidelines. When reused, it must undergo thorough cleaning, disinfection, and sterilization procedures to maintain sterility and prevent cross-contamination. Sterile handling is mandatory during clinical use to ensure patient safety.

  • What regulatory classification and clearance does the IOGYN Endoscope hold?

    The IOGYN Endoscope is classified as a Class II medical device under FDA regulation 884.1690. It has received FDA 510(k) clearance (K123330) through a traditional review process, with the Obstetrics/Gynecology Advisory Committee providing input during its evaluation.

  • Are there specific storage requirements for the IOGYN Endoscope?

    While the provided data does not specify storage conditions, reusable IOGYN Endoscopes should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Single-use devices should be stored according to the manufacturer’s instructions to preserve sterility and functionality until use.