Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012414760

FEI Number

3012414760

Entity Name

Pentax Medical

City/State/Country

Mississauga Ontario, CA

Establishment Address

6715 Millcreek Drive, Unit 1, Mississauga Ontario L5N 5V2, CA

Establishment Type(s)

Remanufacture Medical Device

Owner / Operator

HOYA Corporation PENTAX Division (Owner Number: 8030235)

Owner / Operator Contact Address

3 Paragon Drive, Montvale, NJ 07645, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FIBEROPTIC COLONOSCOPE (FC-38LV-OUS) VIDEO COLONOSCOPE (EC34-I10TL) VIDEO COLONOSCOPE - PTAH (EC38-V10CM-OUS) DISTAL RUBBER HOOD (OE-A59) VIDEO COLONOSCOPE (EC38-i10NL-OUS) VIDEO COLONOSCOPE - CLASSIC LINE (EC-380LKP) VIDEO COLONOSCOPE (EC38-I10CL) VIDEO COLONOSCOPE (EC38-i10NF-OUS) IMAGINA VENTING CAP (OE-C28) VIDEO COLONOSCOPE - PTAH (EC38-V10CL-OUS) VIDEO COLONOSCOPE (EC38-i10L-OUS) CLEANING ADAPTER (OE-C27) VIDEO COLONOSCOPE (EC34-I10CL-OUS) VIDEO COLONOSCOPE (EC34-I10NL-OUS) VIDEO COLONOSCOPE (EC34-i10L-OUS) PENTAX MEDICAL VIDEO COLONOSCOPE (EC38-i20cL) PENTAX Medical Suction Control Valve (OE-B13) PENTAX Medical Cylinder Cleaning Adapter (OE-B16) PENTAX Medical Air/Water Channel Cleaning Adapter (OE-B15) PENTAX Medical Air/Water Feeding Valve (OE-B12) PENTAX Medical Gas/Water Feeding Valve (OE-B14) PENTAX Medical Water Jet Channel Cleaning Adapter (OE-C31)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-10-17

Official Correspondent

Paresh Patel

US Agent Details

Paresh Patel Business: HOYA CORPORATION PENTAX DIVISION Email: paresh.patel@pentaxmedical.com Phone: (201) 5712300

Related Public Records

Same Entity

HOYA Corporation PENTAX Division

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3033588952	HOYA Corporation	Plovdiv, BG
2518897	PENTAX of America, Inc.	MONTVALE, NJ, US
9610877	HOYA Corporation PENTAX Lifecare Division	Akishima-shi Tokyo, JP
3014605202	PENTAX MEDICAL (PENANG) SDN. BHD.	Penang Pulau Pinang, MY
3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP

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9610595	AIZU OLYMPUS CO., LTD.	AIZUWAKAMATSU-SHI Fukushima, JP
3015136743	STERI-TECH CO.,LTD.	KAZO-SHI Saitama, JP
3042225166	FUJIFILM Corporation Medical Systems Research & Development Center Kaisei	Ashigarakami-Gun Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012414760. Last updated year: 2026. Please use registration number 3012414760 when referencing this establishment in official correspondence.