Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014605202

FEI Number

3014605202

Entity Name

PENTAX MEDICAL (PENANG) SDN. BHD.

City/State/Country

Penang Pulau Pinang, MY

Establishment Address

Plot 554, Lorong Perusahaan 4, Prai Free Trade Zone, Penang Pulau Pinang 13600, MY

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

K200090

PMA Number

N/A

All Registered Proprietary Names

STERILE DISPOSABLE ELEVATOR CAP FOR DEC (OE-A65) DEC HD VIDEO DUODENOSCOPE (ED32-i10) VIDEO COLONOSCOPE (EC-3890TLK) VALVE, SUCTION (OF-B120) VIDEO COLONOSCOPE (EC-3490LK) VIDEO COLONOSCOPE (EC-2990LI) TUBE,IRRIGATION FOR 30/40 SERIES (OF-B113) VIDEO COLONOSCOPE (EC-3490TLI) VIDEO COLONOCOPE - I10 STANDARD (EC38-I10L) WATER JET CHECK VALVE ADAPTER REPLACES O (OE-C12) O RING SET FOR OF-B188 (OF-B192) HDVIDEO COLONOSCOPE (EC-3490LI) VIDEO COLONOSCOPE (EC-3890LI) VIDEO COLONOSCOPE - I10 SLIM (EC34-I10L) VIDEO COLONOSCOPE (EC-3890LK) A/W VALVE (OF-B188) OE-C14 CHECK VALVE SET-10 PCS. USE WITH (OE-C15) VIDEO COLONOSCOPE (EC-3890LZI) PENTAX Distal Rubber Hood(OE-A59) O-RING MODEL (OF-B182) PENTAX VIDEO COLONOSCOPE (EC-3890LZi) PENTAX Medical R/L Assistant Knob (OE-B17) PENTAX Medical Video Upper GI Scope (EG27-i20c) PENTAX Medical Video Colonoscope (EC34-i20cL) ULTRASOUND VIDEO GASTROSCOPE (EG-3670URK) ADVANCED DIGITAL ULTRASOUND SYSTEM (HV-PREIRUS) OPTIVISTA HD VIDEO PROCESSOR(EPK-I7010) ULTRASOUND VIDEO GASTROSCOPE (EG-3270UK) HITACHI ARIETTA 70 ULTRASOUND SCANNER (EUS-ARIETTA 70) LINEAR ULTRASOUND VIDEO GASTROSCOPE (EG-3870UTK) VIDEO PROCESSOR (EPK-i5010) TOOL, BALLON ATTACHMENT 2 PCS (OF-A37) LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C (EG-3870UTK) BALLOON/O-RING KIT FOR ULTRASOUND, 20 PCS (OF-A67) SOAKING CAP FOR US CONNECTOR (OE-U1) AIR/WATER/SUCTION METAL OPTIONAL (OF-B153) VIDEO GASTROSCOPE (EG-1690K) HD VIDEO GASTROSCOPE (EG-2990I) VIDEO GASTROSCOPE (EG-3890TK) CLEANING ADAPTER, AIR/WATER (OF-G17) SUCTION CHANNEL SELECTOR FOR EC/EG 70 SE (OF-B161) HD VIDEO GASTROSCOPE (EG-2790I) VIDEO GASTROSCOPE (EG-2790K) O-RING SET FOR OF-B177 SUCTION VALVE (OF-B127) FWJ CLEANING ADAPTER OE-C20 (OE-C20) SILICONE OIL (OF-Z11) VIDEO GASTROSCOPE (EG-3490K) VIDEO GASTROSCOPE (EG27-i10) VIDEO GASTROSCOPE - (EG29-I10) VIDEO GASTROSCOPE (EG-2490K) VIDEO GASTROSCOPE (EG-2990K) CAP, CONNECTOR, FOR WATER JET FOR 30/40 (OF-B118) 2CH CLEANING ADAPTER (OF-B162) VIDEO GASTROSCOPE (EG-2990Zi) VIDEO GASTROSCOPE (EG16-K10) AIR/WATER FEEDING VALVE FOR ULTRASOUND (OF-B172) O-RING SET FOR OF B171 (OF-B187) ADAPTER, AIR/WATER/SUCTION CHANNEL (OE-C5) RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C (EG-3670URK) SUCTION VALVE FOR ULTRASOUND SCOPES (OF-B171) O RING SET FOR OE-U1 (OS-A69) O-RING SET FOR OF-B172 (OF-B191) BALLOON FOR EG-3630UR, 20 PCS (OE-A51) PENTAX Medical single use scope holder, SCH-G2 PENTAX Medical Scope stand, SS-1 PENTAX Medical Video upper GI scope, EG17-J10 VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL11-J10) CLEANING ADAPTER FOR INLET (OF-B218) LAMP FOR EPK-3000 (OL-X30) CLEANING ADAPTER (OF-B212) VIDEO PROCESSOR (EPK-3000) CONDENSER EARTH CABLE (OL-Z4) O RING SET (OF-B214) WHITE BALANCE ADJUSTER (OS-A43H) SOAKING CAP (OE-C9) VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL8-J10) RUBBER INLET SEAL SINGLE PIECE , STD (OF-B190) VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL15-J10) SINGLE USE SUCTION CONTROL VALVE (OF-B205) ETO STERILIZATION VENTING CAP (OF-C5) EPK-PROMO(EPK-3000 Campaign Discount) KEYBOARD FOR EPK-3000 (OS-A94) VIDEO SIGMOIDOSCOPE (ES-3870K) O-RING SET FOR THE OF-B178 A/W VALVE (OF-B184) AIR/WATER/SUCTION RUBBER CHANNEL CLEANING ADAPTER (OF-B166) AIR/WATER FEEDING VALVE FOR 70K/80K SERIES (OF-B183) SUCTION NIPPLE CLEANING ADAPTER (OE-C8) SUCTION VALVE REPLACES OF-B157 70K/80K (OF-B177) VIDEO LARYNGOSTROBOSCOPE (VNL-1590STi) VIDEO LARYNGOSTROBOSCOPE (VLS-1590STI) VIDEO LARYNGOSTROBOSCOPE (VLS-1070STK) RIGID ENDOSCOPE, STERRAD (9109) VIDEO LARYNGOSTROBOSCOPE (VLS-1190STK) LARYNGEAL STROBE (9500) Footswitch for 9500(9500FS) Laryngeal Microphone for 9500(9500LX) Lapel Microphone for 9500(9500MC) VIDEO LARYNGOSTROBOSCOPE (VNL-1190STK) VIDEO LARYNGOSTROBOSCOPE (VNL-1070STK) VIDEO PROCESSOR (CP-1000) VIDEO NASOPHARYNGOLARYNGOSCOPE (VNL9-CP) Leakage test adapter (OE-B9) BALLOON FOR EG-3270UK, 20 PIECES (OE-A56) ELEVATOR WIRE CAP (OE-B3) INJECTION ADAPTER (OE-B5) LINEAR ULTRASOUND VIDEO GASTROSCOPE (EG-3270UK) SINGLE USE DISTAL CAP - ED34-I10T (OE-A62) C.A.P. HD DUODENOSCOPE US (ED34-I10T-US) PENTAX Medical Video Esophagoscope (EE17-J10) Yellow single use cleaning brush(CS5522A) O Ring Set for A/W Valve(OF-B192) Double head single-use cleaning brush(CS-C13A) Ventilation Cap(OE-C21) PENTAX Medical Cylinder Cleaning Adapter (OE-B16) PENTAX Medical Suction control valve OE-B13 PENTAX Medical Video Processor EPK-i8020c PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15 PENTAX Medical Video Upper GI Scope EG29- i20c Pentax Video Colonoscope (EC38-i20cL) PENTAX Medical Water Jet Channel Cleaning Adapter OE-C31 PENTAX Medical Keyboard EN OS-A115 PENTAX Medical Air/Water feeding Valve OE-B12 PENTAX White Balance Adjuster (OS-A43) PENTAX Portable Bronchoscopes (FB-15RBS) FIBEROPTIC BRONCHOSCOPE (FB-8V) SUCTION VAL AUTO, CLAVABLE U/W EB,VB, FB (OF-B136) FIBER OPTIC CABLE FOR BS-LH2 (BS-LC1) FIBEROPTIC BRONCHOSCOPE (FB-15V) BATTERY LIGHT SOURCE - LED (BS-LL1) FIBEROPTIC BRONCHOSCOPE (FB-18V) KIT,O-RING FOR OF-B76 6PCS (OF-B80) CAP,SOAKING FOR PORTABLE BRONCHO BS-B1 (BS-B1) SUCTION VALVE - RUBBER (OF-B53) CAP ELVTR WIRE CLNG INLET (OF-B17) RUBBER SUCTION VALVE (OF-B53) EYEPIECE CAP (OF-D1) Video Bronchoscope (EB15-J10) Video Bronchoscope (EB19-J10) O-RING KIT FOR OF-B95 SUCTION VALVE (OF-B100) SUCTION VALVE AUTO CLAVABLE (OF-B140) PENTAX Naso-Pharyngo-Laryngoscopes (FNL-15RP3) PENTAX BALLOON PKG OF 20PCS (OE-A52) ULTRASOUND VIDEO BRONCHOSCOPE (EB-1970UK) BALLOON INSTALLATION DEVICE (OE-A53) Cleaning Adapter (OE-B11) ULTRASOUND VIDEO BRONCHOSCOPE (EB19-J10U) Scanning Unit Connector Soaking Cap (OE-U4) Single Use Balloon (OE-A61) Junction Box to be used with Preirus Scanner (PUN-JBP1) VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL-1570STK) SMALL BOWEL ENTEROSCOPE (VSB-3430K) KIT, O-RING FOR OF-B33, B54, B77, B78 (OF-B35) PENTAX Medical EG-J10U Endoscopic Ultrasound System (EUS-J10) EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type) EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type) SINGLE USE BALLOON (OE-A60) PENTAX Medical Cleaning Adapter(OE-G1) PENTAX Medical O-Ring Set For EUS-J10 (OF-B219) PENTAX Medical Suction/Balloon Suction Control Valve(OF-B206) CLEANING ADAPTER FOR EG34-J10U (OE-B10) PENTAX Medical Air/Water/balloon Feeding Valve(OF-B207)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-04-28
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-04-22
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-12-09
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-12-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-01-08
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-01-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-05-13
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-05-13
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-04-22
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-05-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-05-13
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-11-03
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2018-04-06
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2018-04-06
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2009-06-05
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2007-06-29
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2018-09-11
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-05-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-05-04
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-10-12
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2023-01-25
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-08-15
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2023-08-15
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-08-15
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2009-06-04
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-12-08
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2009-06-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-04-28
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2014-04-28
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-09-10
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2017-05-04
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2017-05-04
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2006-01-04
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2020-11-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-16

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
3012414760	Pentax Medical	Mississauga Ontario, CA
2518897	PENTAX of America, Inc.	MONTVALE, NJ, US
9610877	HOYA Corporation PENTAX Lifecare Division	Akishima-shi Tokyo, JP
3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220587	Olympus Medical Systems Corp.	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	2022-05-11
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022	Aesthetics Systems Usa Inc	2	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026	ImaCor Inc.	2	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014605202. Last updated year: 2026. Please use registration number 3014605202 when referencing this establishment in official correspondence.