Cleared Special

ARTHRO-SURGIMAT-A103

K000153 · W.O.M. World of Medicine GmbH · Orthopedic

Feb 2000

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K000153 is an FDA 510(k) clearance for the ARTHRO-SURGIMAT-A103, a Arthroscope (Class II — Special Controls, product code HRX), submitted by W.O.M. World of Medicine GmbH (Mansfield, US). The FDA issued a Cleared decision on February 8, 2000, 21 days after receiving the submission on January 18, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K000153 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2000
Decision Date	February 08, 2000
Days to Decision	21 days
Submission Type	Special
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).