SURGICAL LIGHT HANDLE COVER— 510(k) K133554

Name: FDA 510(k) clearance K133554
Creator: U.S. Food and Drug Administration
Published: 2014-04-08

Substantially Equivalent

Microtek Medical, Inc. an Ecolab Company

FDA 510(k) clearance K133554 for SURGICAL LIGHT HANDLE COVER, Substantially Equivalent on 2014-04-08. Applicant: Microtek Medical, Inc. an Ecolab Company. Device class: 2.

Clearance details

Applicant: Microtek Medical, Inc. an Ecolab Company
Product code: Code FTA
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2013-11-19
Decision date: 2014-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTA

view all

K150532 — Universal Light Handle Cover, Light Handle Cover2015-09-22
K142386 — Operating Room Light Handle Adapter2014-09-29
K133413 — IDSS SLC2014-01-07
K112133 — OASYS SURGICAL LIGHT CONTROLLER2012-03-01
K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC)2010-11-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.