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Data / Medical devices / United States / Acteon, Inc.

Acteon, Inc.: FDA-registered device maker in Mount Laurel, NJ, United States, 18 510(k) clearances

Acteon, Inc. is registered with the FDA (registration 2243757) in Mount Laurel, NJ, United States. It lists 24 device types. The FDA files 18 510(k) clearances under its listings, the newest dated May 3, 2018. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Acteon, Inc.
FDA registration number
2243757
Address
1001 Briggs Rd Ste 220, Mount Laurel, NJ, United States, 08054
Owner or operator
SATELEC-ACTEON GROUP (9004992)
Roles
Repackager or relabeler
First device listed
December 10, 2002
Registered through
2026
Brand names listed
Autoclavable Sinuscope, BRONCHOSCOPE (FLEXIBLE OR RIGID), BS1S M+ N STER, BS2L M+ N STER, BS2R M+ N STER, BS5 M+ N STER, BS6 M+ N STER, CE1 M+ N STER and more

Devices it lists

DeviceProduct codeClassRoleSource
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Repackager or relabeleraccessdata.fda.gov
Cord, RetractionMVLURepackager or relabeleraccessdata.fda.gov
Cover, Biopsy ForcepsFFF1Repackager or relabeleraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Repackager or relabeleraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Repackager or relabeleraccessdata.fda.gov
Drill, Bone, PoweredDZI2Repackager or relabeleraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Repackager or relabeleraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-PoweredOCZ2Repackager or relabeleraccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Repackager or relabeleraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Sonic And Accessory/AttachmentJDX2Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Repackager or relabeleraccessdata.fda.gov
OtoscopeERA1Repackager or relabeleraccessdata.fda.gov
ResectoscopeFJL2Repackager or relabeleraccessdata.fda.gov
Resectoscope, Working ElementFDC2Repackager or relabeleraccessdata.fda.gov
Retractor, FiberopticFDG1Repackager or relabeleraccessdata.fda.gov
Scaler, UltrasonicELC2Repackager or relabeleraccessdata.fda.gov
Tripsor, Stone, BladderFGK2Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeleraccessdata.fda.gov
UrethrotomeEZO2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 3, 2018K172137PIEZOTOME CUBEDZISubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
March 10, 2014K132267NEWTRON P5, NEWTRON P5 B.LEDELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
November 26, 2013K131997NEWTRON BOOSTERELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
October 30, 2009K091913HI TECH IMPLANT, HT PHYSIO IMPLANTEKXSubstantially EquivalentBy Dental Srlaccessdata.fda.gov
May 1, 2006K060274PIEZOTOMEDZISubstantially EquivalentSatelecaccessdata.fda.gov
February 11, 2005K050180EXPA-SYLMVLSubstantially EquivalentProduits Dentaires Pierre Rollandaccessdata.fda.gov
August 12, 1997K971881COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORSFJLSubstantially EquivalentComeg Endoscopyaccessdata.fda.gov
May 27, 1997K971202COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPSOCZSubstantially EquivalentComeg Endoskopie GmbHaccessdata.fda.gov
April 22, 1997K970764COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIESOCXSubstantially EquivalentComeg Endoscopyaccessdata.fda.gov
March 19, 1997K970489COMEG ENDOSCOPY GRASPING FORCEPSFFLSubstantially EquivalentComeg Endoscopyaccessdata.fda.gov
February 2, 1996K945264OPTUS OTOSCOPESERASubstantially EquivalentOptus, Inc.accessdata.fda.gov
January 22, 1996K953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESHRXSubstantially EquivalentOptus, Inc.accessdata.fda.gov
December 21, 1995K945268OPTUS BRONCHOSCOPESEOQSubstantially EquivalentOptus, Inc.accessdata.fda.gov
September 12, 1995K945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPESHIHSubstantially EquivalentOptus, Inc.accessdata.fda.gov
May 26, 1995K945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESFAJSubstantially EquivalentOptus, Inc.accessdata.fda.gov
January 26, 1995K944656OPTUS SINUSCOPES AND ACCESSORIESEOBSubstantially EquivalentOptus, Inc.accessdata.fda.gov
November 7, 1994K945269OPTUS LARYNGOSCOPESCCWSubstantially EquivalentOptus, Inc.accessdata.fda.gov
April 5, 1993K923876RISKONTROL SINGLE USEECBSubstantially EquivalentRiskontrolaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
February 19, 201673459Class IIOngoingJuno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibitedaccessdata.fda.gov
August 5, 201571958Class IITerminatedVilla Sistemi Rotograph EVO 3D X-rayIt has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).accessdata.fda.gov
December 14, 201470241Class IITerminatedJuno DFR X-ray systemThe system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionalityaccessdata.fda.gov
August 2, 201366024Class IITerminatedJuno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy proceduresIt has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6accessdata.fda.gov

Compare with other makers

Updated May 3, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.