Product code FTA— General, Plastic Surgery

FDA has cleared 26 devices under product code FTA between 1978 and 2015, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20151 clearance
• 20143 clearances
• 20121 clearance
• 20101 clearance
• 20081 clearance
• 20061 clearance
• 20051 clearance
• 20031 clearance
• 20022 clearances
• 19991 clearance
• 19961 clearance
• 19941 clearance
• 19921 clearance
• 19901 clearance
• 19894 clearances

• KARL STORZ Endoscopy-America, Inc.3 clearances
• Transmedical Corp.2 clearances
• Image Stream Medical, Inc.2 clearances
• Xodus Medical, Inc.1 clearance
• Welcon, Inc.1 clearance
• Vistek Corp.1 clearance
• Professional Medical Products, Inc.1 clearance
• Oasys Healthcare1 clearance
• Microtek Medical, Inc. an Ecolab Company1 clearance
• Microbio-Medics, Inc.1 clearance

• K150532 — Universal Light Handle Cover, Light Handle CoverKey Surgical, Inc.·2015-09-22
• K142386 — Operating Room Light Handle AdapterLitex Manufacturing, Inc.·2014-09-29
• K133554 — SURGICAL LIGHT HANDLE COVERMicrotek Medical, Inc. an Ecolab Company·2014-04-08
• K133413 — IDSS SLCBlack Diamond Video·2014-01-07
• K112133 — OASYS SURGICAL LIGHT CONTROLLEROasys Healthcare·2012-03-01
• K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.·2010-11-23
• K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.·2008-07-30
• K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXodus Medical, Inc.·2006-01-19
• K051505 — SCB/STERIS OR-LIGHT INTERFACE BOXKARL STORZ Endoscopy-America, Inc.·2005-08-11
• K023704 — KSEA SCB ACC CONTROLKARL STORZ Endoscopy-America, Inc.·2003-01-30
• K020640 — KSEA SCB MEDIA CONTROLKARL STORZ Endoscopy-America, Inc.·2002-05-28
• K020304 — DISPOSABLE LIGHT HANDLE AND ADAPTORAspen Surgical Products, Inc.·2002-02-14
• K993089 — DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTERDeroyal Cardiovascular, Inc.·1999-10-14
• K954940 — MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLEMdt Biologic Co.·1996-01-17
• K935102 — SATURN LIGHTBurton Medical Products Corp.·1994-06-27
• K915068 — PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVERAmerican Medical Mfg., Inc.·1992-02-06
• K901154 — MICROTEK'S SURGICAL LAMP HANDLE & COVERMicrobio-Medics, Inc.·1990-03-20
• K894397 — WELCON LIGHT HANDLEWelcon, Inc.·1989-08-10
• K890866 — TC SYSTEM-HANDLETransmedical Corp.·1989-03-14
• K890867 — TC SYSTEM-COVERTransmedical Corp.·1989-03-14
• K890539 — SURE COUNT LIGHT HANDLE COVERKleen Test Products·1989-02-27
• K882132 — LIGHT, SURGICAL ACCESSORIESCharles Polo & Co., Inc.·1988-06-15
• K871034 — LCA 2000Vistek Corp.·1987-04-10
• K862010 — CHICK SURGICAL LIGHTProfessional Medical Products, Inc.·1986-06-09
• K810292 — CAM-WRAPMedline Industries, Inc.·1981-03-04
• K780162 — DIGAPHOT PHOTOTHERAPY METER MODEL PT 145Cavitron Corp.·1978-03-27