Cleared Traditional

K221965 - FemDx FalloView
(FDA 510(k) Clearance)

K221965 · Femdx Medsystems, Inc. · Obstetrics & Gynecology
Mar 2023
Decision
255d
Days
Class 2
Risk

K221965 is an FDA 510(k) clearance for the FemDx FalloView, a Falloposcope (Class II — Special Controls, product code MKO), submitted by Femdx Medsystems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 17, 2023, 255 days after receiving the submission on July 5, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K221965 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2022
Decision Date March 17, 2023
Days to Decision 255 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MKO — Falloposcope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690