Cleared Traditional

PUREVUE? FMS

K250795 · W.O.M. World of Medicine GmbH · Orthopedic

Dec 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K250795 is an FDA 510(k) clearance for the PUREVUE? FMS, a Arthroscope (Class II — Special Controls, product code HRX), submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on December 5, 2025, 266 days after receiving the submission on March 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K250795 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2025
Decision Date	December 05, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).