Cleared Traditional

VIDEOSCOPE W/IRRIGATION SHEATH

K954016 · T. Korossurgical Instruments Corp. · Orthopedic

Jan 1996

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K954016 is an FDA 510(k) clearance for the VIDEOSCOPE W/IRRIGATION SHEATH, a Arthroscope (Class II — Special Controls, product code HRX), submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on January 25, 1996, 153 days after receiving the submission on August 25, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K954016 FDA.gov
FDA Decision	Cleared SN
Date Received	August 25, 1995
Decision Date	January 25, 1996
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

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).