K850393Substantially Equivalent

Flexible Fiberoptic Endoscope

Name: K850393 Flexible Fiberoptic Endoscope
Creator: Microvasive
Published: 1985-06-04
License: https://open.fda.gov/license/

Microvasive, Milford MA / Traditional, Substantially Equivalent

FDA source

K850393 is the FDA 510(k) clearance record for FLEXIBLE FIBEROPTIC ENDOSCOPE, cleared for Microvasive on 1985-06-04. FDA records list 18 510(k) clearances for Microvasive, from 1983-11-14 to 1987-10-09. As of 2026-09-10, FDA records show no recalls naming K850393.

Clearance record

Decision date: 1985-06-04
Received: 1985-02-01 (123 days to decision)
Review panel: Unknown
Applicant: Microvasive 31 Maple St., Milford MA
Third party review: No