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Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532)

by Hangzhou Viction Medical Technology Co., Ltd

510(k) K250130

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 NumberK250130 Date6 Aug 2025ClearedStatusActive

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  • Withdrawn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
GCJ
Models / Variants
FDA applicant
Hangzhou Viction Medical Technology Co.,Ltd
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Viction Disposable Irrigation and Suction System is a Class II medical device designed for use during endoscopic procedures. It provides irrigation and suction capabilities to facilitate visualization and performance during gastrointestinal and urological procedures.

This disposable system is supplied in multiple model variants and is intended for single-use applications. The device is regulated under 21 CFR 876.1500 as an endoscope accessory and has received FDA 510(k) clearance with K number K250130. It is manufactured by Hangzhou Viction Medical Technology Co., Ltd.

Other devices from Hangzhou Viction Medical Technology Co., Ltd

Questions

AI-generated answers, 24 Sep 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 Viction Disposable Irrigation and Suction System used for?

    The Viction Disposable Irrigation and Suction System is designed for use during endoscopic procedures, providing irrigation and suction capabilities to facilitate visualization and performance during gastrointestinal and urological procedures.

  • How is the Viction Disposable Irrigation and Suction System supplied?

    The system is supplied in multiple model variants including VC-FLA0514, VC-FLA0523, VC-FLA0532, VC-FLB0514, VC-FLB0523, VC-FLB0532, VC-FLC0514, VC-FLC0523, VC-FLC0532, VC-FLD0514, VC-FLD0523, and VC-FLD0532, each designed for specific procedural requirements.

  • Is the Viction Disposable Irrigation and Suction System single-use or reusable?

    The Viction Disposable Irrigation and Suction System is intended for single-use applications only. It should not be reused or resterilized for any purpose to ensure patient safety and device performance.

  • What is the regulatory status of the Viction Disposable Irrigation and Suction System?

    The device has received FDA 510(k) clearance with K number K250130 and is regulated under 21 CFR 876.1500 as an endoscope accessory. It is classified as a Class II medical device and was determined to be substantially equivalent.