Cleared Traditional

ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES

K950592 · Eare Consulting Service · Orthopedic

Jun 1995

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K950592 is an FDA 510(k) clearance for the ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Eare Consulting Service (Eilat, IL). The FDA issued a Cleared decision on June 1, 1995, 112 days after receiving the submission on February 9, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K950592 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 1995
Decision Date	June 01, 1995
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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).