ACTEON, INC.

Registration Details

Registration Name: ACTEON, INC.
Registration Number: 2243757
FEI Number: 2243757
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 1001 Briggs Rd Ste 220
City: Mount Laurel
State: NJ
ZIP: 08054
Country: US

Regulatory Submissions

510(k) Number: K091913

Owner / Operator

Firm Name: SATELEC-ACTEON GROUP
Operator Number: 9004992
Address: 1001 Briggs Rd, Suite 220
City: Mount Laurel
State: NJ
Postal Code: 08054
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Handpiece, Direct Drive, Ac-Powered	EKX	Class 1	Dental	No	2011-11-03
Endoscopic Irrigation/Suction System	OCX	Class 2	Gastroenterology, Urology	No	2006-10-18
Arthroscope	HRX	Class 2	Orthopedic	No	2006-10-18
Hysteroscope (And Accessories)	HIH	Class 2	Obstetrics/Gynecology	No	2006-10-18
Scaler, Ultrasonic	ELC	Class 2	Dental	No	2014-03-13
Unit, Syringe, Air And/Or Water	ECB	Class 1	Dental	No	2016-06-14
Otoscope	ERA	Class 1	Ear, Nose, Throat	No	2006-10-18
Dislodger, Stone, Basket, Ureteral, Metal	FFL	Class 2	Gastroenterology, Urology	No	2006-10-18
Drill, Bone, Powered	DZI	Class 2	Dental	No	2018-05-03
Endoscopic Grasping/Cutting Instrument, Non-Powered	OCZ	Class 2	Gastroenterology, Urology	No	2006-10-18
Tripsor, Stone, Bladder	FGK	Class 2	Gastroenterology, Urology	No	2006-10-18
Forceps	HTD	Class 1	General, Plastic Surgery	No	2006-10-18
Bronchoscope (Flexible Or Rigid)	EOQ	Class 2	Ear, Nose, Throat	No	2006-10-18
Cover, Biopsy Forceps	FFF	Class 1	Gastroenterology, Urology	No	2006-10-18
Retractor, Fiberoptic	FDG	Class 1	Gastroenterology, Urology	No	2006-10-18
Electrode, Electrosurgical, Active, Urological	FAS	Class 2	Gastroenterology, Urology	No	2006-10-18
Resectoscope	FJL	Class 2	Gastroenterology, Urology	No	2006-10-18
Resectoscope, Working Element	FDC	Class 2	Gastroenterology, Urology	No	2006-10-18
Urethrotome	EZO	Class 2	Gastroenterology, Urology	No	2006-10-18
Instrument, Surgical, Sonic And Accessory/Attachment	JDX	Class 2	Orthopedic	No	2017-10-20
Nasopharyngoscope (Flexible Or Rigid)	EOB	Class 2	Ear, Nose, Throat	No	2006-10-18
Laryngoscope, Rigid	CCW	Class 1	Anesthesiology	No	2006-10-18
Cystoscope And Accessories, Flexible/Rigid	FAJ	Class 2	Gastroenterology, Urology	No	2006-10-18
Cord, Retraction	MVL	Class U	Unknown	No	2016-06-14

Proprietary Names

I-SURGE + ENDOSCOPY RESECTOSCOPE ACCESSORIES HYSTEROSCOPE AND ACCESSORIES NEWTRON P5 B.LED NEWTRON P5 Riskontrol OTOSCOPE AND ACCESSORIES ENDOSCOPY GRASPING FORCEPS PIEZOTOME CUBE OPTICAL STONE CRUSHING FORCEPS COMEG ENDOSCOPY GRASPING FORCEPS Newtron Booster Ultrasonic Scaler BRONCHOSCOPE (FLEXIBLE OR RIGID) COMEG ENDOSCOPY BIOPSY FOR ENDOSCOPY BIOPSY FORCEP SCION FIBEROPTIC RETRACTOR WORKING ELEMENT RESECTOSCOPE RISKONTROL PIEZOTOME M+ Bone Surgery Tips PIEZOTOME M+ Bone Surgery Tips: RHS1, RHS2Fb, RHS2Hb, RHS3L, RHS3R, RHS4L, RHS4R, RHS5, RHL5, RHS6 NINJA M+ N STER CE2 M+ N STER INSERT BS1 RD M+ N STER INSERT SL2 M+ N STER INSERT BS2L XL M+ N STER SL4 M+ N STER INSERT BS1 XXL M+ N STER BS5 M+ N STER PIEZOTOME SOLO M+ US LC1 XL M+ N STER SL5 M+ N STER KIT RHS EXPERT M+ N STER LC1 M+ N STER INSERT BS2R XL M+ N STER CS6 M+ N STER INSERT BS6 XXL M+ N STER TKW5 M+ N STER INSERT SL3 M+ N STER KIT CMF NON STERILE TIP RHS3L M+ N STER INSERT SL1 M+ N STER TKW4 M+ N STER CS4 M+ N STER LC2 M+ N STER INSERT BS4 M+ N STER INSERT RHS4L N STER TKW2 M+ N STER CE3 M+ N STER INSERT RHS2Fb N STER CS1 M+ N STER BS1S M+ N STER INSERT RHS2Hb N STER TKW1 M+ N STER TIP RHS5 M+ N STER CS2 M+ N STER TKW3 M+ N STER DB 2 M+ N STER CS3 M+ N STER CE1 M+ N STER TIP RHS6 M+ N STER TIP RHS3R M+ N STER BS2R M+ N STER INSERT RHS4R N STER KIT RHS BASIC M+ N STER BS6 M+ N STER INSERT BS1L M+ N STER LC2R M+ N STER BS2L M+ N STER INSERT RHS1 N STER LC2L M+ N STER CS5 M+ N STER DB 1 M+ N STER RHL4R M+ RHL5 M+ RHL6 M+ RHL2 RHL4L M+ PIEZOTOME Drill, Bone , Powered Autoclavable Sinuscope ULYSS SINUSCOPES AND ACCESSORIES RIGID LARYNGOSCOPE CYSTOSCOPE AND ACCESSORIES RETREAT GRP Expasyl RETREAT GRP

Establishment Types

Repack or Relabel Medical Device