Cleared Traditional

DISCOSCOPES, CERVICAL ENDOSCOPES

K130778 · Rz Medizintechnik GmbH · Orthopedic

Apr 2014

Decision

389d

Days

Class 2

Risk

About This 510(k) Submission

K130778 is an FDA 510(k) clearance for the DISCOSCOPES, CERVICAL ENDOSCOPES, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Rz Medizintechnik GmbH (M?hlheim An Der Donau, DE). The FDA issued a Cleared decision on April 14, 2014, 389 days after receiving the submission on March 21, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K130778 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2013
Decision Date	April 14, 2014
Days to Decision	389 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).