Avenda Health Treatment System
K-Number: K201687 · 2020-11-30
ApplicantAvenda Health, Inc.
Decision Date2020-11-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Avenda Health Treatment System is a medical device manufactured by Avenda Health, Inc.. It received FDA 510(k) clearance on 2020-11-30 under approval number K201687. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Avenda Health Treatment System?
Avenda Health Treatment System is a medical device that received FDA 510(k) clearance on 2020-11-30. It is manufactured by Avenda Health, Inc.. The 510(k) number is K201687.
When was Avenda Health Treatment System approved by the FDA?
Avenda Health Treatment System received FDA 510(k) clearance on 2020-11-30, under approval number K201687.
What company makes Avenda Health Treatment System?
Avenda Health Treatment System is manufactured by Avenda Health, Inc..
What is the FDA product code for Avenda Health Treatment System?
The FDA product code for Avenda Health Treatment System is GEX. This falls under the Gastroenterology category.
Related Clinical Trials
NCT07614997
Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck
NOT_YET_RECRUITING
NCT07194317
A Feasibility Study to Determine the Most Appropriate Digital Dietary Assessment Tool in Patients With Obesity Initiating GLP-1 Receptor Agonist Treatment
COMPLETED
NCT06727942
Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes
RECRUITING
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
NCT06940752
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
ENROLLING_BY_INVITATION
NCT06868914
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 41887630
Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa.
BMJ open (2026)
PMID: 41879133
Medical Device Regulation - Who Does the FDA Serve?
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)
PMID: 41790854
A Substance Use Disorder Virtual Treatment and Research Platform: A Proof of Concept.
IEEE pulse (2025)
PMID: 41734979
Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review.
Yonsei medical journal (2026)
Other Devices by Avenda Health, Inc.
Related Devices (Code: GEX)
K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.
K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.
K163222Discovery Pico FamilyQuanta System Spa
K163009LithoQuanta System Spa
K162191NAVILAS Laser SystemOd-Os GmbH
K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.