Cleared Traditional

K202582 - Arthrex SynergyID Endoscopic Imaging Sy...

K202582 is the FDA 510(k) clearance for Arthrex SynergyID Endoscopic Imaging Sy... by Arthrex, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K202582 · Arthrex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
317d
Days
Class 2
Risk

K202582 is an FDA 510(k) clearance for the Arthrex SynergyID Endoscopic Imaging System. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 22, 2021 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K202582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2020
Decision Date July 22, 2021
Days to Decision 317 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 115d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 693
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K202582.
RedEx
K211234 · Advanced Surgical Concepts, Ltd. · Sep 2021
HandX
K212214 · Human Xtensions , Ltd. · Sep 2021
Lab Bag with Fabric Pouch
K210248 · Advanced Medical Design Co., Ltd. · Jul 2021
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
K203717 · Fujifilm Corporaton · Jun 2021
Cor-Knot Micro
K202551 · Lsi Solutions, Inc. · Jun 2021
VisionPort System
K211250 · New View Surgical, Inc. · Jun 2021