510 (k) Premarket Notification - Food and Drug Administration
4 days ago · 510K Number Type Traditional Special Abbreviated Product Code Center Biologics Evaluation and Research Devices and Radiological Health Combination Products Applicant Name …
FDA 510(k) Explained: A Basic Guide to Premarket Notification
Nov 19, 2025 · The FDA’s guidance document, Evaluating Substantial Equivalence in Premarket Notifications (510k), contains the agency’s requirements for this. The Abbreviated 510 (k)
FDA 510 (k) Clearance Explained: How It Works (2025 Guide)
Jun 19, 2025 · Learn what a 510 (k) is, how FDA clearance works, and when medical devices need 510 (k) approval. Plain-English guide for 2025.
What Is a 510 (k) Submission? A Complete 2025 Guide
Jan 14, 2025 · Learn every step in preparing and submitting a 510k, from device class and substantial equivalence to eSTAR and review timelines.
510 (k) Clearances | FDA
Overview of Section 510 (k) Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 ...
What Is FDA 510k? A Complete Guide to FDA 510k Certification
Jun 26, 2025 · FDA 510k, also known as Premarket Notification, is a submission that companies must file with the U.S. Food and Drug Administration (FDA) before marketing most medical devices in the …
Context It is important for medical device innovators to become familiar with the types of FDA Market Authorization applications and identify the one most applicable to their development program. The …
Essential Components of a Winning Medical Device Submission …
2 days ago · This post breaks down the essential components to build that strategy, helping you navigate FDA 510k strategy, PMA submission, and Health Canada device license processes with …
NIPRO’s Avantec Vascular Receives FDA 510 (k) Clearance for DVT ...
Feb 3, 2026 · Avantec Vascular, a NIPRO Company, receives FDA 510(k) clearance for a new DVT-focused thrombectomy system designed to improve treatment and patient outcomes.
Median Technologies Receives FDA 510 (k) Clearance for eyonis® LCS, …
3 days ago · eyonis® LCS aims to redefine lung cancer screening by supporting diagnosis at early, curable stages, while reducing false positives to avoid unnecessary follow-up procedures, and has …