FDA Registration Active 🇯🇵 Japan

HOYA Corporation PENTAX Lifecare Division

Reg #: 9610877 · FEI: 3008185830 · Expires 2026
Products
31
Proprietary Names
405
Establishment Types
3
Classifications
31

Registration Details

Registration Name
HOYA Corporation PENTAX Lifecare Division
Registration Number
9610877
FEI Number
3008185830
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Tsutsujigaoka 1-1-110
City
Akishima-shi Tokyo
Country
JP

Regulatory Submissions

510(k) Number
K023376

Owner / Operator

Firm Name
HOYA Corporation PENTAX Division
Operator Number
8030235
Address
3 Paragon Drive
City
Montvale
State
NJ
Postal Code
07645
Country
US
Correspondent
Paresh Patel

US Agent

Business Name
HOYA CORPORATION PENTAX DIVISION
Contact Name
Paresh Patel
Address
3 Paragon Drive
City
Montvale
State
NJ
ZIP
07645
Country
US
Phone
201 5712300 ext. 2312

Products

Device Name Product Code
Laryngostroboscope EQL
Bronchoscope (Flexible Or Rigid) EOQ
Endoscope, Accessories, Image Post-Processing For Color Enhancement PEA
Endoscopic Ultrasound System, Gastroenterology-Urology ODG
Duodenoscope And Accessories, Flexible/Rigid FDT
Forceps, Biopsy, Electric KGE
Colonoscope And Accessories, Flexible/Rigid FDF
Endoscopic Bite Block MNK
Gastrointesinal Lesion Software Detection System QNP
Gastroscope And Accessories, Flexible/Rigid FDS
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
Ureteroscope And Accessories, Flexible/Rigid FGB
Transducer, Ultrasonic, Diagnostic ITX
Medical Device Data System OUG
Nasopharyngoscope (Flexible Or Rigid) EOB
Choledochoscope And Accessories, Flexible/Rigid FBN
Cystoscope And Accessories, Flexible/Rigid FAJ
Esophagoscope, General & Plastic Surgery GCL
Esophagoscope (Flexible Or Rigid) EOX
Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
Accessories, Cleaning Brushes, For Endoscope MNL
Snare, Flexible FDI
Endoscopic Irrigation/Suction System OCX
Endoscope Channel Accessory ODC
Laryngoscope, Non-Rigid CAL
Bulb, Inflation, For Endoscope FCY
Electrosurgical, Cutting & Coagulation & Accessories GEI
Light Source, Fiberoptic, Routine FCW
Attachment, Teaching, For Endoscope FEA
Light Source, Endoscope, Xenon Arc GCT
Sigmoidoscope And Accessories, Flexible/Rigid FAM

Proprietary Names

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) FORCEPS 3FR CUPS REUSABLE 1DIA 110L (KS-1011CS) CLEANING ADAPTER, SUCTION CHANNEL (OF-B75) VIDEO BRONCHOSCOPE (EB-1990i) SUCTION VALVE REPLACES OF-B154 70K SLIM (OF-B179) VIDEO BRONCHOSCOPE (EB-1575K) VIDEO BRONCHOSCOPE (EB-1975K) VIDEO BRONCHOSCOPE (EB-1970K) SUCTION CHANNEL CLEANING ADAPTER FOR EB (OF-B155) VIDEO BRONCHOSCOPE (EB-1570K) VIDEO BRONCHOSCOPE (EB-1170K) O-RING SET FOR OF-B179 3 PCS (OF-B181) VIDEO BRONCHOSCOPE (EB-1970TK) VIDEO PROCESSOR (EPK-i5010) 300W XENON LAMP KIT W/HOUSING- EPK-I5010 (OL-X27) ADAPTER SLEEVE FOR FIBERSCOPE (OF-G1) VENTING CAP (OE-C21) DISTAL RUBBER TIP FOR ED34-I10T (OE-A55) VIDEO DUODENOSCOPE (ED-34-i10T) VIDEO DUODENOSCOPE (ED32-i10) SINGLE USE, STERILE DISTAL CAP FOR SLIM DEC (OE-A65) VIDEO DUODENOSCOPE (ED-3490TK) PENTAX Medical Video Duodenoscope (ED34-i10cT) PENTAX Medical Video Duodenoscope (ED34-i10cT2) HEMOSTASIS FORCEPS, WD2.6, LN1800, QTY 5 (HS-D2618) HEMOSTASIS FORCEPS, WD2.6, LN2200, QTY 5 (HS-D2622) Video Colonoscope (EC34-i10TL-US) SINGLE USE DISTAL CAP - ED34-I10T (OE-A62) C.A.P. HD DUODENOSCOPE US (ED34-I10T-US) BITE BLOCK (OF-Z5) PENTAX Medical Smart Assistant System SAS-M10 PENTAX Medical Smart Assistant System SAS-M10- IMAGINA COLONOSCOPE (EC34-i10CL) IMAGINA VENTING CONNECTOR ADAPTER (OE-C29) VIDEO GASTROSCOPE (EG29-i10C) VIDEO PROCESSOR (EPK-i5500C) IMAGINA COLONOSCOPE (EC38-i10CL) PENTAX Medical keyboard EN (OS-A111) PENTAX Medical Ventilation Cap(OE-C28) PENTAX Medical keyboard EN (OS-A116) VIDEO PROCESSOR (EPK-P-OUS) SCOPEPILOT (NCU-7000) NCU-7000 CABLE (OS-A98) VIDEO PROCESSOR - (EPK-1000-OUS) NCU-7000 FIELD GENERATOR UNIT (OS-A95) NCU-7000 REMOTE CONTROL UNIT (OS-A99) NCU-7000 KEYBOARD (OS-A97) NCU-7000 EXTERNAL POSITION SENSOR (OS-A100) PENTAX Medical Field Generator Stand (OS-A96-OUS) VIDEO PROCESSOR - INTERNATIONAL (EPK-1000-INTL) FIBER OPTIC URETEROSCOPE (FUR-9RBS-OUS) VALVE IRRIGATION CESSATION (OF-B105) 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 Camera Head (PVK-J10) PENTAX Medical Endoscope Mount Adapter for Rigid Ocular Endoscopes (AP-RV3) FIBEROPTIC CHOLANGIO-PANCREATOSCOPE (FCP-9P-OUS) INTRODUCER,PROTECTVE SCOPE, FOR FCP-9P (OF-B107) IRRIGATION CESSATION VALVE (OF-B151) VIDEO CYSTOSCOPE (ECY-1575K-OUS) VIDEO CYSTOSCOPE (ECY-1570K-OUS) IRRIGATION ACTIVATION VALVE FOR FCY SCOPES (OF-B152) IRRIGATION ACTIVATION VALVE FOR ECY SCOPES (OF-B164) IRRIGATION CESSATION VALVE, USE W/ ECY-70/70K (OF-B163) FIBEROPTIC CYSTOSCOPE (FCY-15RBS-OUS) STERILE DISPOSABLE ELEVATOR CAP FOR DEC (OE-a63) DEC HD VIDEO DUODENOSCOPE (ED34-I10T2) Ventilation Cap(OE-C21) VIDEO GASTROSCOPE (EG34-i10) PENTAX Medical single use scope holder, SCH-G2 PENTAX Medical Scope stand, SS-1 PENTAX Medical Video upper GI scope, EG17-J10 SMALL BOWEL ENTEROSCOPE (VSB-3430K) KIT, O-RING FOR OF-B33, B54, B77, B78 (OF-B35) VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE (VNL-1070STK-OUS) FIBER NASO PHARYNGO LARYNGOSCOPE (FNL-10RBS) VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE (VNL-1190STK-OUS) VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL-1590STi-OUS)) Video Bronchoscope (EB15-J10) Video Bronchoscope (EB19-J10) TUBE, CLEANING FOR ELEVATOR WIRE (OF-B10) CLEANING ADAPTER, SUCTION CHANNEL (OF-B65) PVE Soaking Cap(OE-C2) O-RING KIT FOR OF-B95 SUCTION VALVE (OF-B100) SUCTION VALVE AUTO CLAVABLE (OF-B140) PENTAX Naso-Pharyngo-Laryngoscopes (FNL-15RP3) SEAL, LUER LOCK ADJUSTABLE (OF-B82) CLEANING ADAPTER, SUCTION CHANNEL (OF-B103) O-Ring (OF-B84) VIDEO ESOPHAGOSCOPE (EE17-J10-OUS) PENTAX Medical Video Processor (EPK-i8020c) REUSABLE WATERBOTTLE (OS-H5) Water Bottle Cleaning Adapter (OS-A63) PENTAX Medical Keyboard EN (OS-A115) 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) 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) EYEPIECE ADAPTER FOR PTX FIBER PVA PVK (AP-PV1) EYEPIECE ADAPTER FOR OLY OES PVA PVK (AP-OV1) EYEPIECE ADAPTOR (AP-RV1) 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) 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) VIDEO GASTROSCOPE (EG-2990Zi-OUS) VIDEO SMALL BOWEL ENTEROSCOPE (VSB-2990I-OUS) FIBEROPTIC GASTROSCOPE (FG-29V-OUS) FIBEROPTIC GASTROSCOPE (FG-24V-OUS) ADAPTER, WATER JET CHECK-VALVE UNIT FOR 30 (OF-B119) VIDEO GASTROSCOPE (EG16-K10-OUS) VIDEO GASTROSCOPE (EG29-V10C-OUS) VIDEO GASTROSCOPE (EG27-V10C-OUS) VIDEO GASTROSCOPE (EG-290KP-OUS) DISTAL RUBBER HOOD FOR EG-2990ZI (OE-A58) VIDEO GASTROSCOPE (EG17-J10) IMAGINA STANDARD HD GASTROSCOPE (EG29-I10C) PENTAX MEDICAL VIDEO UPPER GI SCOPE EG29-i20c Light Guide Plug Cap (OE-C23-OUS) CLEANING BRUSH, TD6.O LN210CM (CS-6021SN) CLEANING BRUSH TD3,LN250CM FOR 30/40 S (CS-3025S) CLEANING BRUSHES - 10 PER PACK (CS-6021T) CLEANING BRUSH RESUABLE (CS-C9S) CLEANING BRUSH, TD LN300CM (CS-6030SN) A/W, S & FWJ CYLINDER CLEANING (CS-C5S) CLEANING BRUSH (OF-Z14) REUSE SUCTION / IRRCYL BRUSH 7.6DIA 1PC (CS-C2S) Single Use Channel Cleaning Brush (CS2022A) Single Use Channel Cleaning Brush (CS4010A) Single Use Channel Cleaning Brush (CS5522A) CLEANING BRUSH (CS-6002SN) CLEANING BRUSH (CS-6015ST) Single use Port/ Cylinder Brush (CS-C13A) Single use Port/ Cylinder Brush (CS-11A) Single use Port/ Cylinder Brush (CS-12A) PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS-C11A) Cleaning brushes for endoscope cylinder (CS-C3S) PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS5530A) PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS5503A) Cleaning Brushes for Endoscope Channels (CS3010S) PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits(CS3022A) PENTAX Medical PROFILE Single Use Endoscope Cleaning Brush Kits (CS2010A) SNARE, WD2.6, LN2200 (DO-D2622) SNARE, WD2.6, LN1800 (DO-D2618) 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) 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) 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) O-RING SET, BLACK - 6PCS (OF-B143) CLEANING ADAPTER, AIR/WATER (OF-BG2) VALVE, AIR/WATER (OF-B121) CLEANING ADAPTER, AIR/WATER/SUCTION (OF-B115) VALVE, AIR/WATER (OF-B77) V-Ring for Air Water Feeding Valves OF-B77/OF-B96/OF-B123/OF-B132 (OF-B138) 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) PENTAX Medical Gas/Water Feeding Valve (OE-B14) FIBEROPTICINTUBATIONSCOPE (FI-13RBS) CAP, EYEPIECE FOR RIGID PNTX OCLR (OF-D6) FIBEROPTICINTUBATIONSCOPE (FI-7RBS) FIBEROPTICINTUBATIONSCOPE (FI-9RBS) FIBEROPTICINTUBATIONSCOPE (FI-10RBS) FIBEROPTICINTUBATIONSCOPE (FI-16RBS) FIBEROPTIC BRONCHOSCOPE (FB-10V-OUS) FIBEROPTIC BRONCHOSCOPE (FB-15RBS-OUS) VIDEO BRONCHOSCOPE (EB19-J10) VIDEO BRONCHOSCOPE (EB15-J10) FIBEROPTIC BRONCHOSCOPE (FB-19TV-OUS) FIBEROPTIC BRONCHOSCOPE (FB-18RBS-OUS) VIDEO BRONCHOSCOPE (EB11-J10) BALLOON FOR EG-3270UK, 20 PIECES (OE-A56) ELEVATOR WIRE CAP (OE-B3) INJECTION ADAPTER (OE-B5) LINEAR ULTRASOUND VIDEO GASTROSCOPE (EG-3270UK) O-RING SET BLACK 5 PCS. USE W/ OE-C12 (OE-C19) R/L ENLARGEMENT KNOB (OE-B1) R/L ENLARGEMENT KNOB FOR 70/80K 90I/90K (OE-B4) VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL-1570STK) VIDEO ESOPHAGOSCOPE (EE-1580K) RUBBER DISTAL TIP, SLIP ON FOR EG-2980K (OE-A41) RUBBER INLET SEAL SINGLE PIECE, STD (OF-B173) AIR CLEANING BRUSH ADAPTER (OF-B170) WATER JET CHECK VALVE ADAPTER(OF-B119) PENTAX Medical R/L Assistant Knob (OE-B17) PENTAX Medical Video Upper GI Scope (EG27-i20c) PENTAX Medical Video Colonoscope (EC34-i20cL) 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 Air/Water Channel Cleaning Adapter (OE-B15) PENTAX Medical Air/Water Feeding Valve (OE-B12) PENTAX Medical Water Jet Channel Cleaning Adapter (OE-C31) SELECTOR MECHANISM, EUS SCOPES (OF-B141) SUCTION VALVE (OF-B58) Leakage Tester SHA-P5 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) ELECTROSURGICAL KNIFE, WD2.5, LN1800 (DP-D2518) ELECTROSURGICAL KNIFE, WD2.7, LN2200 (DN-D2722B) ELECTROSURGICAL KNIFE, WD2.6, LN2200 (DP-D2622) ELECTROSURGICAL KNIFE, WD2.7, LN1800 (DN-D2718B) ELECTROSURGICAL KNIFE, WD2.6, LN1800 (DC-D2618) OF-B205, Sterile Single-use Suction Control Valve EB11-J10, Pentax Medical Video Bronchoscope AIR/WATER FEEDING VALVE (OF-B67) VIDEO PROCESSOR (CP-1000) VIDEO NASOPHARYNGOLARYNGOSCOPE (VNL9-CP) Leakage test adapter (OE-B9) LAMP KIT, LH-150PC (OL-H4) Irrigation Cessation Valves(OF-B163) Irrigation Activation Valves(OF-B152) Irrigation Activation Valves(OF-B164) ADPTR,SCPE,PNTX TO STORZ LS (AL-SL) ADPTR,SCOPE,PNTX GI P- SERIES TO OLY CL2 (AL-OLG11) EYESHIELD (OF-D3) O-RING SET,U/W OFB78 OFB102 FEEDING VALV (OF-B111) ADPTR,SCPE,PNTX TO WOLF LS (AL-WL) ADPTR,SCPE,PNTX TO OLY ILK LS (AL-OL7) ADPTR,SCOPE,PNTX P-SERIES TO OLY CL20,CL (AL-OL11) ADPTR,SCPE,PNTX, TO OLY OES10/20,CLK4 LS (AL-OL9) ADPTR,SCPE,PNTX TO ACMI LS (AL-AL) VALVE, CO2/WATER (OF-B130) AIR / WATER C02 GAS VALVE (OF-B194) LIGHT SOURCE ADAPTER FOR OLYMPUS FIBERSC (Al-OR3) O-RING SET FOR OF-B194 (OF-B195) LIGHT SOURCE ADAPTER FOR OLYMPUS FIBERSC (AL-MF3) ADPTR,SCPE,PNTX TO OLY CLVU20,CLK4 LS (AL-OL10) LAMP FOR EPK-I7010, 300W XENON (OL-X29) VIDEO PROCESSOR (EPK-I7010) KEYBOARD FOR EPK-I7010 (OS-A83) PENTAX Medical Ultrasound Upper GI Video Scope (EG34-J10U) PENTAX Medical Ultrasound Upper GI Video Scope (EG36-J10UR) SUCTION/ SUCTION CHANNEL/ CONTROL VALVE FOR EG34-J10U (OF-B206) AIR/ WATER/ BALLOON CHANNEL FEEDING VALVE FOR EG34-J10U (OF-B207) CLEANING ADAPTER FOR EG34-J10U (OE-G1) PENTAX Medical Ultrasound Upper GI Video Scope (EG38-J10UT) PENTAX Medical O-Ring Set for EUS-J10 (OF-B219) ADAPTER, CO2 GAS (OF-G11) 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) WATER BOTTLE ASSEMBLY AUTOCLAVABLE (OS-H4) VIDEO PROCESSOR (EPK-3000-OUS) VIDEO PROCESSOR - INTERNATIONAL (EPK-I7010-OUS) VIDEO PROCESSOR, (EPK-i5500c-OUS) VIDEO PROCESSOR - (EPK-I5010-OUS) VIDEO PROCESSOR - (EPK-V1500C-OUS) IMAGINA I-SCAN SOFTWARE KEY (OS-I14) PENTAX Medical EXIF Viewer (OS-I20) PENTAX MEDICAL VIDEO PROCESSOR (EPK-i8020c) FORCEPS 3FR CUPS REUSABLE 1DIA 220L (KS-1022CS) ADAPTER, TCH SCOPE, PENTAX TO SCOPE W/RIGID OCULAR (AT-UR2) VIDEO ADAPTER MODULE EPK W/OUT EYEPIECE (PVK-1070Z) ADAPTER,TCH SCOPE, RIGID TO PENTAX SCOPE (AT-ST2) F16-34 Zoom Coupler (S_413024) VIVIDEO CAMERA COUPLER (S_081-006) VIVIDEO CAMERA (PVK-CP) CAMERA HEAD (PVK-J10) ADAPTER, EYEPIECE/RIGID OCULAR (AP-RV3) FIBER NASO PHARYNGO LARYNGOSCOPE (FNL-7RP3) FIBER NASO PHARYNGO LARYNGOSCOPE (FNL-10RP3) PENTAX Portable Naso-Pharyngo-Laryngoscope (FNL-10RBS) PENTAX Medical Video Duodenoscope (ED34-i10T2s) STERILE DISPOSABLE ELEVATOR CAP FOR DEC (OE-A65) DEC HD VIDEO DUODENOSCOPE (ED32-i10) PENTAX Medical Video Colonoscope (EC38-i20cWL) VIDEO PROCESSOR US (EPK-1000) EPK-1000 VIDEO PROCESSOR BUNDLE (KUM-EPK-1000-US) PENTAX Medical Video Colonoscopes (EC34-i10L) PENTAX Medical Video Colonoscopes (EC38-i10L) PENTAX Medical Video Upper GI Scopes (EG-3890TK) PENTAX Medical Video Upper GI Scopes (EG29-i10) PENTAX Medical Video Upper GI Scopes (EG27-i10) PENTAX Medical Video Colonoscopes (EC-3890TLK) PENTAX Medical Video Colonoscopes (EC-2990Li) PENTAX Medical Video Upper GI Scopes (EG-2990i) PENTAX Medical Video Colonoscopes (EC-3890Li) PENTAX Medical Video Upper GI Scopes (EG-2490K) PENTAX BALLOON PKG OF 20PCS (OE-A52) ULTRASOUND VIDEO BRONCHOSCOPE (EB-1970UK) BALLOON INSTALLATION DEVICE (OE-A53) 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)

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device