510(k) K253580— Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

Substantially Equivalent

Tedan Surgical Innovations

Clearance details

Applicant: Tedan Surgical Innovations
Product code: Code PDQ
Advisory panel: Ear, Nose, Throat
Date received: 2025-11-17
Decision date: 2026-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.