Cleared Traditional

Arthrex Synergy Vision Endoscopic Imaging System

K250728 · Arthrex, Inc. · General & Plastic Surgery

May 2025

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K250728 is an FDA 510(k) clearance for the Arthrex Synergy Vision Endoscopic Imaging System, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 5, 2025, 55 days after receiving the submission on March 11, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K250728 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2025
Decision Date	May 05, 2025
Days to Decision	55 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).