FTA · Class II · 21 CFR 878.4580

FDA Product Code FTA: Light, Surgical, Accessories

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Transmedical Corp. and Image Stream Medical, Inc..

26
Total
26
Cleared
67d
Avg days
1978
Since

FDA 510(k) Cleared Light, Surgical, Accessories Devices (Product Code FTA)

26 devices
1–24 of 26
Cleared Sep 22, 2015
Universal Light Handle Cover, Light Handle Cover
K150532
Key Surgical, Inc.
General & Plastic Surgery · 204d
Cleared Sep 29, 2014
Operating Room Light Handle Adapter
K142386
Litex Manufacturing, Inc.
General & Plastic Surgery · 33d
Cleared Apr 08, 2014
SURGICAL LIGHT HANDLE COVER
K133554
Microtek Medical, Inc. an Ecolab Company
General & Plastic Surgery · 140d
Cleared Jan 07, 2014
IDSS SLC
K133413
Black Diamond Video
General & Plastic Surgery · 61d
Cleared Mar 01, 2012
OASYS SURGICAL LIGHT CONTROLLER
K112133
Oasys Healthcare
General & Plastic Surgery · 219d
Cleared Nov 23, 2010
EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
K102791
Image Stream Medical, Inc.
General & Plastic Surgery · 57d
Cleared Jul 30, 2008
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
K081698
Image Stream Medical, Inc.
General & Plastic Surgery · 43d
Cleared Jan 19, 2006
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER
K053321
Xodus Medical, Inc.
General & Plastic Surgery · 50d
Cleared Aug 11, 2005
SCB/STERIS OR-LIGHT INTERFACE BOX
K051505
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 65d
Cleared Jan 30, 2003
KSEA SCB ACC CONTROL
K023704
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 87d
Cleared May 28, 2002
KSEA SCB MEDIA CONTROL
K020640
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 90d
Cleared Feb 14, 2002
DISPOSABLE LIGHT HANDLE AND ADAPTOR
K020304
Aspen Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Oct 14, 1999
DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
K993089
Deroyal Cardiovascular, Inc.
General & Plastic Surgery · 28d
Cleared Jan 17, 1996
MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
K954940
Mdt Biologic Co.
General & Plastic Surgery · 79d
Cleared Jun 27, 1994
SATURN LIGHT
K935102
Burton Medical Products Corp.
General & Plastic Surgery · 248d
Cleared Feb 06, 1992
PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER
K915068
American Medical Mfg., Inc.
General & Plastic Surgery · 90d
Cleared Mar 20, 1990
MICROTEK'S SURGICAL LAMP HANDLE & COVER
K901154
Microbio-Medics, Inc.
General & Plastic Surgery · 7d
Cleared Aug 10, 1989
WELCON LIGHT HANDLE
K894397
Welcon, Inc.
General & Plastic Surgery · 21d
Cleared Mar 14, 1989
TC SYSTEM-HANDLE
K890866
Transmedical Corp.
General & Plastic Surgery · 21d
Cleared Mar 14, 1989
TC SYSTEM-COVER
K890867
Transmedical Corp.
General & Plastic Surgery · 21d
Cleared Feb 27, 1989
SURE COUNT LIGHT HANDLE COVER
K890539
Kleen Test Products
General & Plastic Surgery · 24d
Cleared Jun 15, 1988
LIGHT, SURGICAL ACCESSORIES
K882132
Charles Polo & Co., Inc.
General & Plastic Surgery · 26d
Cleared Apr 10, 1987
LCA 2000
K871034
Vistek Corp.
General & Plastic Surgery · 24d
Cleared Jun 09, 1986
CHICK SURGICAL LIGHT
K862010
Professional Medical Products, Inc.
General & Plastic Surgery · 12d

About Product Code FTA - Regulatory Context