Cleared Traditional

ARTHRO-SURGIMAT

K962114 · W.O.M. World of Medicine GmbH · Orthopedic

Aug 1996

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K962114 is an FDA 510(k) clearance for the ARTHRO-SURGIMAT, a Arthroscope (Class II — Special Controls, product code HRX), submitted by W.O.M. World of Medicine GmbH (Washington, US). The FDA issued a Cleared decision on August 22, 1996, 83 days after receiving the submission on May 31, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K962114 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 1996
Decision Date	August 22, 1996
Days to Decision	83 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).