Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610877

FEI Number

3008185830

Entity Name

HOYA Corporation PENTAX Lifecare Division

City/State/Country

Akishima-shi Tokyo, JP

Establishment Address

Tsutsujigaoka 1-1-110, Akishima-shi Tokyo 196-0012, JP

Establishment Type(s)

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

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

K771739

PMA Number

N/A

All Registered 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 Video Processor (EPK-i8020c) 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) Ventilation Cap(OE-C21) 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 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) 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2007-06-29
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2006-01-04
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2014-04-22
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2013-05-13
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2006-01-04
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-10-25
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2017-12-12
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-11-21
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-10-12
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2018-04-06
QNP	Gastrointesinal Lesion Software Detection System	Gastroenterology, Urology	Class 2	876.1520	2022-03-15
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2019-12-26
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-12-26
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-12-26
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-10-28
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-10-29
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
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2023-01-25
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2023-01-25
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2023-01-25
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2023-01-25
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-10-16
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-10-16
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-11-15
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-08-09
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-11-03
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2006-01-04
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2017-10-16
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-12-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2009-06-05
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2009-06-05
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2009-06-05
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2002-03-09
GCL	Esophagoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-10-22
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2025-06-09
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	Class 2	876.1500	2019-11-12
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-01-25
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
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2023-01-25
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2009-06-04
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	2014-04-22
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-10-17
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2014-05-13
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2017-12-12
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	2019-09-10
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
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2007-06-29
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
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2023-12-04
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2023-12-04
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2007-06-29
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2017-10-16
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
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2009-06-05
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	2009-06-04
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
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-10-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2006-01-04
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2006-01-04
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2006-01-04
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2012-02-07
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-12-12
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-11-02
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2009-12-14
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2018-09-11
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2006-01-04

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
3014605202	PENTAX MEDICAL (PENANG) SDN. BHD.	Penang Pulau Pinang, MY
3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
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.

Similar Registrations

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2518897	PENTAX of America, Inc.	MONTVALE, NJ, US
3016458459	Shenzhen Heearly Technology Co.,Ltd.	Bao an District, Shenzhen Guangdong, CN
3015515531	STEUTE TECHNOLOGIES GMBH & CO. KG	Loehne North Rhine-Westphalia, DE
3007532396	EUSA GLOBAL LLC	Medley, FL, US
3013247477	Arvato SE	Hamburg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610877. Last updated year: 2026. Please use registration number 9610877 when referencing this establishment in official correspondence.