Cleared Traditional

K101609 - SELF RETAINING SOFT TISSUE RETRACTOR
(FDA 510(k) Clearance)

K101609 · Koros USA, Inc. · Orthopedic
Dec 2010
Decision
184d
Days
Class 1
Risk

K101609 is an FDA 510(k) clearance for the SELF RETAINING SOFT TISSUE RETRACTOR, a Orthopedic Manual Surgical Instrument (Class I — General Controls, product code LXH), submitted by Koros USA, Inc. (Moorepark, US). The FDA issued a Cleared decision on December 9, 2010, 184 days after receiving the submission on June 8, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K101609 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2010
Decision Date December 09, 2010
Days to Decision 184 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code LXH — Orthopedic Manual Surgical Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540