Cleared Special

ARTHRO-SURGIMAT-1500

K983910 · W.O.M. World of Medicine GmbH · Orthopedic

Nov 1998

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K983910 is an FDA 510(k) clearance for the ARTHRO-SURGIMAT-1500, 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 November 25, 1998, 22 days after receiving the submission on November 3, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K983910 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 1998
Decision Date	November 25, 1998
Days to Decision	22 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).