Cleared Special

SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE

K063688 · The Anspach Effort, Inc. · Orthopedic

Jan 2007

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K063688 is an FDA 510(k) clearance for the SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 16, 2007, 35 days after receiving the submission on December 12, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K063688 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2006
Decision Date	January 16, 2007
Days to Decision	35 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820