Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2243757

FEI Number

2243757

Entity Name

ACTEON, INC.

City/State/Country

Mount Laurel, NJ, US

Establishment Address

1001 Briggs Rd Ste 220, Mount Laurel, NJ 08054, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SATELEC-ACTEON GROUP (Owner Number: 9004992)

Owner / Operator Contact Address

1001 Briggs Rd, Suite 220, Mount Laurel, NJ 08054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 ENDOSCOPY GRASPING FORCEPS COMEG ENDOSCOPY GRASPING FORCEPS Newtron Booster Ultrasonic Scaler BRONCHOSCOPE (FLEXIBLE OR RIGID) COMEG ENDOSCOPY BIOPSY FOR ENDOSCOPY BIOPSY FORCEP SCION FIBEROPTIC RETRACTOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2011-11-03
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2006-10-18
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2006-10-18
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2006-10-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2014-03-13
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2016-06-14
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2006-10-18
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2006-10-18
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2018-05-03
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2006-10-18
FGK	Tripsor, Stone, Bladder	Gastroenterology, Urology	Class 2	876.4500	2006-10-18
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-10-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2013-12-03
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2006-10-18
FFF	Cover, Biopsy Forceps	Gastroenterology, Urology	Class 1	876.1075	2006-10-18
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2006-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SATELEC-ACTEON GROUP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9615782	SOPRO	LA CIOTAT CEDEX Bouches-du-Rhone, FR
8044015	SATELEC-ACTEON GROUP	MERIGNAC Gironde, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0015-2023	Hobbs Medical, Inc.	2	Hobbs Medical Polypectomy Snare Catalog Number: 4563
Z-0016-2023	Hobbs Medical, Inc.	2	Hobbs Medical Polypectomy Snare Catalog Number: 4564

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3017604	ASEPTICO, INC.	WOODINVILLE, WA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2243757. Last updated year: 2026. Please use registration number 2243757 when referencing this establishment in official correspondence.