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Arthrex Synergy UHD4 System

by Arthrex, Inc.

510(k) K153218

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153218 Date12 Feb 2016ClearedStatusActive

Official records

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  • Withdrawn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
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 23 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 Arthrex Synergy UHD4 System is a medical device used in gastroenterology and urology procedures. It is designed to provide high-definition visualization and assistance during endoscopic and urological interventions.

The system is supplied by Arthrex, Inc. and received FDA 510(k) clearance on February 12, 2016, with the K number K153218. It is a reusable device that should be stored according to the manufacturer's instructions, and its use is authorized for medical settings where gastroenterology and urology procedures are performed.

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