Cleared Traditional

ARTHRO-Pump PA304

K173311 · W.O.M. World of Medicine GmbH · Orthopedic

May 2018

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K173311 is an FDA 510(k) clearance for the ARTHRO-Pump PA304, 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 May 9, 2018, 203 days after receiving the submission on October 18, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K173311 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2017
Decision Date	May 09, 2018
Days to Decision	203 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).