FDA.reportPublic FDA data

ACTEON, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22437572243757ACTEON, INC.1Y2026-01-011001 Briggs Rd Ste 220 Mount Laurel NJ US 08054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
133181619517759K971881COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORSFJL1997-08-12
133181121690050K971202COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPSOCZ1997-05-27
133181857721732K970764COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIESOCX1997-04-22
133182043745906K970489COMEG ENDOSCOPY GRASPING FORCEPSFFL1997-03-19
133181934507610K953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESHRX1996-01-22
133181425834505K945269OPTUS LARYNGOSCOPESCCW1994-11-07
133181672312178K945268OPTUS BRONCHOSCOPESEOQ1995-12-21
133181016977378K945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPESHIH1995-09-12
133181807709284K945264OPTUS OTOSCOPESERA1996-02-02
133181330852070K945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESFAJ1995-05-26
133181649140195K944656OPTUS SINUSCOPES AND ACCESSORIESEOB1995-01-26
133181988472545K923876RISKONTROL SINGLE USEECB1993-04-05
133181373939613K172137PIEZOTOME CUBEDZI2018-05-03
133181103741412K132267NEWTRON P5, NEWTRON P5 B.LEDELC2014-03-10
133181665391599K131997NEWTRON BOOSTERELC2013-11-26
133181264956875K091913HI TECH IMPLANT, HT PHYSIO IMPLANTEKX2009-10-30
133181182674427K060274PIEZOTOMEDZI2006-05-01
133181191768124K050180EXPA-SYLMVL2005-02-11
133181050754091
133181163809908
133181327355218
133181462420477
133181763119954

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZI22018-05-03
ELC22014-03-10
EKX12009-10-30
MVL12005-02-11
FJL11997-08-12
OCZ11997-05-27
OCX11997-04-22
FFL11997-03-19
ERA11996-02-02
HRX11996-01-22
EOQ11995-12-21
HIH11995-09-12
FAJ11995-05-26
EOB11995-01-26
CCW11994-11-07
ECB11993-04-05