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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
FCP
Box, Battery, Pocket
1
Product Code
FCQ
Light Source, Incandescent, Diagnostic
2
Product Code
EXQ
Cystometer, Electrical Recording
2
Product Code
EXR
Urinometer, Mechanical
2
Product Code
EXS
Urinometer, Electrical
2
Product Code
EXW
Pill, Radio
2
Product Code
EXY
Uroflowmeter
2
Product Code
EXZ
Equipment, Photographic, For Physiologic Function Monitor
1
Product Code
FAJ
Cystoscope And Accessories, Flexible/Rigid
2
Product Code
FAK
Panendoscope (Gastroduodenoscope)
2
Product Code
FAL
Panendoscope (Urethroscope)
2
Product Code
FAM
Sigmoidoscope And Accessories, Flexible/Rigid
2
Product Code
FAN
Sigmoidoscope, Rigid, Electrical
2
Product Code
FAP
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
2
Product Code
FBI
Rongeur, Cystoscopic
2
Product Code
FBK
Endoscopic Injection Needle, Gastroenterology-Urology
2
Product Code
FBN
Choledochoscope And Accessories, Flexible/Rigid
2
Product Code
FBO
Cystourethroscope
2
Product Code
FBP
Telescope, Rigid, Endoscopic
2
Product Code
FCC
Endoscopic Magnetic Retriever
2
Product Code
FCF
Instrument, Biopsy, Mechanical, Gastrointestinal
2
Product Code
FCG
Biopsy Needle
2
Product Code
FCI
Punch, Biopsy
2
Product Code
FCK
Instrument, Biopsy, Suction
2
Product Code
FCL
Forceps, Biopsy, Non-Electric
1
Product Code
FCO
Box, Battery, Rechargeable
1
Product Code
FCR
Light Source, Photographic, Fiberoptic
2
Product Code
FCW
Light Source, Fiberoptic, Routine
2
Product Code
FCX
Insufflator, Automatic Carbon-Dioxide For Endoscope
2
Product Code
FCY
Bulb, Inflation, For Endoscope
1
Product Code
FCZ
Tube, Smoke Removal, Endoscopic
1
Product Code
FDA
Enteroscope And Accessories
2
Product Code
FDC
Resectoscope, Working Element
2
Product Code
FDE
Laparoscopy Kit
2
Product Code
FDF
Colonoscope And Accessories, Flexible/Rigid
2
Product Code
FDR
Sphyncteroscope
2
Product Code
FDS
Gastroscope And Accessories, Flexible/Rigid
2
Product Code
K
23
2997
EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
2
Cleared 510(K)
K
23
2919
Ambu® aScope™ Gastro Large; Ambu® aBox™ 2
2
Cleared 510(K)
K
23
2028
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
2
Cleared 510(K)
K
23
2314
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
2
Cleared 510(K)
K
22
1551
FUJIFILM Endoscope Model EI-740D/S
2
Cleared 510(K)
K
21
3606
EvoEndo Single-Use Endoscopy System
2
Cleared 510(K)
K
21
2382
Ambu® aScope™ Gastro, Ambu® aBox™2
2
Cleared 510(K)
K
21
0177
PENTAX Medical Video Upper GI Scopes EG17-J10
2
Cleared 510(K)
K
21
2296
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
2
Cleared 510(K)
K
21
0915
Pathfinder Endoscope Cap
2
Cleared 510(K)
K
21
0485
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
2
Cleared 510(K)
K
21
0162
Endoscope Model EI-740D/S
2
Cleared 510(K)
K
19
2704
Endofresh Digestive Endoscopy System
2
Cleared 510(K)
K
20
0850
Fujifilm Ultrasonic Processor
2
Cleared 510(K)
K
19
3123
FUJIFILM Distal Cap Models 33-40
2
Cleared 510(K)
K
19
0799
PENTAX Medical Video Upper GI Scopes (EG Family)
2
Cleared 510(K)
K
18
3572
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
2
Cleared 510(K)
K
18
2836
FUJIFILM Endoscope Model EG-740N
2
Cleared 510(K)
K
18
3686
FUJIFILM Endoscope Model EG-530N
2
Cleared 510(K)
K
18
0292
PENTAX Video Upper G.I. Scope EG34-i10
2
Cleared 510(K)
K
18
0341
FUJIFILM 600 Series Endoscope EG-600WR v2
2
Cleared 510(K)
K
18
1763
FUJIFILM Ultrasonic Endoscope
2
Cleared 510(K)
K
18
0911
Visura Technologies TEECAD System
2
Cleared 510(K)
K
17
3004
SB Soft Hood - Straight type, SB Soft Hood - Undercut type
2
Cleared 510(K)
K
17
2916
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
2
Cleared 510(K)
K
16
2749
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
2
Cleared 510(K)
K
15
3206
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
2
Cleared 510(K)
K
15
2182
Fuse Gastroscopy System
2
Cleared 510(K)
K
14
2629
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
2
Cleared 510(K)
K
14
0295
GIS ENDOSCOPIC OPTICAL LENS
2
Cleared 510(K)
K
13
1902
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
2
Cleared 510(K)
K
13
1422
PEERSCOPE SYSTEM
2
Cleared 510(K)
K
13
0148
FOREIGN BODY HOOD
2
Cleared 510(K)
K
12
3317
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
2
Cleared 510(K)
K
12
0446
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
2
Cleared 510(K)
K
11
3166
CLEARPATH UPPER GI
2
Cleared 510(K)
K
11
1243
FUJINON ULTRASONIC PROCESSOR
2
Cleared 510(K)
K
09
3779
CLEARPATH UGI
2
Cleared 510(K)
K
06
3316
FUJINON MODEL EG-530N TRANS NASAL INSERTION
2
Cleared 510(K)
K
06
3847
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
2
Cleared 510(K)
K
06
0907
KARL STORZ VIDEO GASTROSCOPES
2
Cleared 510(K)
K
04
2043
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
2
Cleared 510(K)
K
03
2177
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I
2
Cleared 510(K)
K
02
1886
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
2
Cleared 510(K)
K
01
3640
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
2
Cleared 510(K)
K
01
1151
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
2
Cleared 510(K)
K
00
2231
LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT
2
Cleared 510(K)
K
00
1766
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
2
Cleared 510(K)
K
98
4358
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
2
Cleared 510(K)
K
97
4493
FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES
2
Cleared 510(K)
K
97
1734
VG 200 VIDEO GASTROSCOPE
2
Cleared 510(K)
K
97
1660
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
2
Cleared 510(K)
K
96
3023
ULTRASOUND GASTROSCOPE GF TYPE UM30P
2
Cleared 510(K)
K
96
2897
EG-3400, VIDEO GASTROSCOPE
2
Cleared 510(K)
K
96
2460
EG-3800T, VIDEO GASTROSCOPE
2
Cleared 510(K)
K
96
1564
EG-2940, VIDEO GASTROSCOPE
2
Cleared 510(K)
K
94
3715
VISION SYSTEM UPPER G.I. EXDOSCOPE
2
Cleared 510(K)
K
93
3717
OLYMPUS MEASURING DEVICES
2
Cleared 510(K)
K
85
0020
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
2
Cleared 510(K)
K
83
3924
TWO CHANNEL GASTROFIBERSCOPE FG-36T
2
Cleared 510(K)
K
83
2007
PENTAX FG-34JA GASTROFIBERSCOPE
2
Cleared 510(K)
FDT
Duodenoscope And Accessories, Flexible/Rigid
2
Product Code
FDW
Esophagoscope, Rigid, Gastro-Urology
2
Product Code
FDX
Endoscopic Cytology Brush
2
Product Code
FDY
Device, Measuring, For Panendoscope
1
Product Code
FDZ
Attachment, Eyepiece, For Insertion Of Prescription Lens
1
Product Code
FEA
Attachment, Teaching, For Endoscope
1
Product Code
FEC
Obturator, For Endoscope
2
Product Code
FED
Endoscopic Access Overtube, Gastroenterology-Urology
2
Product Code
FEI
Instrument, Special Lens, For Endoscope
1
Product Code
FEJ
Attachment, Binocular, For Endoscope
1
Product Code
FEM
Accessories, Photographic, For Endoscope (Exclude Light Sources)
1
Product Code
FEN
Device, Cystometric, Hydraulic
2
Product Code
FEQ
Pump, Air, Non-Manual, For Endoscope
2
Product Code
FER
Anoscope And Accessories
2
Product Code
FES
Recorder, External, Pressure, Amplifier & Transducer
2
Product Code
FET
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
2
Product Code
FFF
Cover, Biopsy Forceps
1
Product Code
FFG
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
2
Product Code
FFS
Image, Illumination, Fiberoptic, For Endoscope
2
Product Code
FFT
Electrode, Ph, Stomach
1
Product Code
FFX
System, Gastrointestinal Motility (Electrical)
2
Product Code
FFY
Adaptor, Bulbs, Miscellaneous, For Endoscope
1
Product Code
FFZ
Cord, Electric, For Endoscope
2
Product Code
FGA
Kit, Nephroscope
2
Product Code
FGB
Ureteroscope And Accessories, Flexible/Rigid
2
Product Code
FGC
Urethroscope
2
Product Code
FGS
Carrier, Sponge, Endoscopic
2
Product Code
FHO
Pneumoperitoneum Needle
2
Product Code
FHP
Needle, Pneumoperitoneum, Simple
2
Product Code
FHX
Jelly, Lubricating, For Transurethral Surgical Instrument
2
Product Code
FJL
Resectoscope
2
Product Code
FTI
Lamp, Endoscope, Incandescent
2
Product Code
FTJ
Colonoscope, General & Plastic Surgery
2
Product Code
GCF
Proctoscope
2
Product Code
GCK
Gastroscope, General & Plastic Surgery
2
Product Code
GCL
Esophagoscope, General & Plastic Surgery
2
Product Code
GCM
Endoscope, Rigid
2
Product Code
GCN
Endoscope, Prism
2
Product Code
GCO
Endoscope, Mirror
2
Product Code
GCP
Endoscope, Ac-Powered And Accessories
2
Product Code
GCQ
Endoscope, Flexible
2
Product Code
GCS
Endoscope, Battery-Powered And Accessories
2
Product Code
GCT
Light Source, Endoscope, Xenon Arc
2
Product Code
GCW
Transformer, Endoscope
2
Product Code
GDB
Endoscope, Fiber Optic
2
Product Code
KDM
Sigmoidoscope, Rigid, Non-Electrical
2
Product Code
KDO
Rongeur, Cystoscopic, Hot
2
Product Code
KGD
Scissors For Cystoscope
2
Product Code
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
2
Product Code
KNW
Instrument, Biopsy
2
Product Code
MNK
Endoscopic Bite Block
1
Product Code
MNL
Accessories, Cleaning Brushes, For Endoscope
1
Product Code
MYE
System, Electrogastrography (Egg)
2
Product Code
NBG
Marker, Colon
2
Product Code
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
2
Product Code
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
2
Product Code
NLS
Instrument, Biopsy, Reprocessed
2
Product Code
NLX
Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
2
Product Code
NMX
Needle And Needle Set, Gastro-Urology, Reprocessed
2
Product Code
NMY
Needle, Endoscopic, Reprocessed
2
Product Code
NON
Forceps, Biopsy, Non-Electric, Reprocessed
1
Product Code
NSI
System, Imaging, Esophageal, Wireless, Capsule
2
Product Code
NTN
Led Light Source
2
Product Code
NWB
Endoscope, Accessories, Narrow Band Spectrum
2
Product Code
NYV
Gastrointestinal Motility System, Capsule
2
Product Code
NWS
Kit, Choledochoscope, Flexible And Rigid
2
Product Code
NWT
Endoscopic Cholangiogram Kit
2
Product Code
NWU
Endoscope Introducer Kit
2
Product Code
OCS
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
2
Product Code
OCT
Anti Fog Solution And Accessories, Endoscopy
2
Product Code
OCU
Endoscopic Storage Cover
2
Product Code
OCV
Endoscope Holder
2
Product Code
OCW
Endoscopic Tissue Approximation Device
2
Product Code
OCX
Endoscopic Irrigation/Suction System
2
Product Code
OCY
Endoscopic Guidewire, Gastroenterology-Urology
2
Product Code
OCZ
Endoscopic Grasping/Cutting Instrument, Non-Powered
2
Product Code
ODA
Endoscopic Central Control Unit
2
Product Code
ODB
Endoscopic Contamination Prevention Sheath
2
Product Code
ODC
Endoscope Channel Accessory
2
Product Code
ODD
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
2
Product Code
ODE
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
2
Product Code
ODF
Mini Endoscope, Gastroenterology-Urology
2
Product Code
ODG
Endoscopic Ultrasound System, Gastroenterology-Urology
2
Product Code
PCV
Endoscopic Leak Tester
2
Product Code
PEA
Endoscope, Accessories, Image Post-Processing For Color Enhancement
2
Product Code
PGD
Colon Capsule Imaging System
2
Product Code
PGU
Spatial Imaging For Display Of Endoscope Position
2
Product Code
PHT
Basin For Endoscope Reprocessing
1
Product Code
PLL
Submucosal Injection Agent
2
Product Code
POZ
Biopsy Needle Kit
2
Product Code
PPE
Nephroscope Set
2
Product Code
PRV
Gastro-Urology Biopsy Kit
2
Product Code
PTQ
Endoscopic Magnetic Retriever, Exempt
2
Product Code
QFZ
Gastroenterology-Urology Accessories To A Biopsy Instrument
1
Product Code
PTR
Scissors For Cytoscope, Exempt
2
Product Code
PTS
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
2
Product Code
QIJ
Endoscopic Transhepatic Venous Access Needle
2
Product Code
QIS
Esophageal, Mucosal, Electrical Characterization
2
Product Code
QKZ
Magnetically Maneuvered Capsule Endoscopy System
2
Product Code
QNP
Gastrointesinal Lesion Software Detection System
2
Product Code
SBX
Software For Endoscopy Procedure Metrics
2
Product Code
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
General Hospital
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Hematology
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Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
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Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
GU
/
subpart-b—diagnostic-devices
/
FDS
/
K192704
View Source
Endofresh Digestive Endoscopy System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192704
510(k) Type
Traditional
Applicant
HuiZhou Xzing Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/2/2020
Days to Decision
341 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
FCP
Box, Battery, Pocket
FCQ
Light Source, Incandescent, Diagnostic
EXQ
Cystometer, Electrical Recording
EXR
Urinometer, Mechanical
EXS
Urinometer, Electrical
EXW
Pill, Radio
EXY
Uroflowmeter
EXZ
Equipment, Photographic, For Physiologic Function Monitor
FAJ
Cystoscope And Accessories, Flexible/Rigid
FAK
Panendoscope (Gastroduodenoscope)
FAL
Panendoscope (Urethroscope)
FAM
Sigmoidoscope And Accessories, Flexible/Rigid
FAN
Sigmoidoscope, Rigid, Electrical
FAP
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
FBI
Rongeur, Cystoscopic
FBK
Endoscopic Injection Needle, Gastroenterology-Urology
FBN
Choledochoscope And Accessories, Flexible/Rigid
FBO
Cystourethroscope
FBP
Telescope, Rigid, Endoscopic
FCC
Endoscopic Magnetic Retriever
FCF
Instrument, Biopsy, Mechanical, Gastrointestinal
FCG
Biopsy Needle
FCI
Punch, Biopsy
FCK
Instrument, Biopsy, Suction
FCL
Forceps, Biopsy, Non-Electric
FCO
Box, Battery, Rechargeable
FCR
Light Source, Photographic, Fiberoptic
FCW
Light Source, Fiberoptic, Routine
FCX
Insufflator, Automatic Carbon-Dioxide For Endoscope
FCY
Bulb, Inflation, For Endoscope
FCZ
Tube, Smoke Removal, Endoscopic
FDA
Enteroscope And Accessories
FDC
Resectoscope, Working Element
FDE
Laparoscopy Kit
FDF
Colonoscope And Accessories, Flexible/Rigid
FDR
Sphyncteroscope
FDS
Gastroscope And Accessories, Flexible/Rigid
K
23
2997
EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
K
23
2919
Ambu® aScope™ Gastro Large; Ambu® aBox™ 2
K
23
2028
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
K
23
2314
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K
22
1551
FUJIFILM Endoscope Model EI-740D/S
K
21
3606
EvoEndo Single-Use Endoscopy System
K
21
2382
Ambu® aScope™ Gastro, Ambu® aBox™2
K
21
0177
PENTAX Medical Video Upper GI Scopes EG17-J10
K
21
2296
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
K
21
0915
Pathfinder Endoscope Cap
K
21
0485
PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
K
21
0162
Endoscope Model EI-740D/S
K
19
2704
Endofresh Digestive Endoscopy System
K
20
0850
Fujifilm Ultrasonic Processor
K
19
3123
FUJIFILM Distal Cap Models 33-40
K
19
0799
PENTAX Medical Video Upper GI Scopes (EG Family)
K
18
3572
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
K
18
2836
FUJIFILM Endoscope Model EG-740N
K
18
3686
FUJIFILM Endoscope Model EG-530N
K
18
0292
PENTAX Video Upper G.I. Scope EG34-i10
K
18
0341
FUJIFILM 600 Series Endoscope EG-600WR v2
K
18
1763
FUJIFILM Ultrasonic Endoscope
K
18
0911
Visura Technologies TEECAD System
K
17
3004
SB Soft Hood - Straight type, SB Soft Hood - Undercut type
K
17
2916
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
K
16
2749
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
K
15
3206
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
K
15
2182
Fuse Gastroscopy System
K
14
2629
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
K
14
0295
GIS ENDOSCOPIC OPTICAL LENS
K
13
1902
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
K
13
1422
PEERSCOPE SYSTEM
K
13
0148
FOREIGN BODY HOOD
K
12
3317
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
K
12
0446
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
K
11
3166
CLEARPATH UPPER GI
K
11
1243
FUJINON ULTRASONIC PROCESSOR
K
09
3779
CLEARPATH UGI
K
06
3316
FUJINON MODEL EG-530N TRANS NASAL INSERTION
K
06
3847
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
K
06
0907
KARL STORZ VIDEO GASTROSCOPES
K
04
2043
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
K
03
2177
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I
K
02
1886
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
K
01
3640
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K
01
1151
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
K
00
2231
LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT
K
00
1766
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
K
98
4358
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
K
97
4493
FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES
K
97
1734
VG 200 VIDEO GASTROSCOPE
K
97
1660
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
K
96
3023
ULTRASOUND GASTROSCOPE GF TYPE UM30P
K
96
2897
EG-3400, VIDEO GASTROSCOPE
K
96
2460
EG-3800T, VIDEO GASTROSCOPE
K
96
1564
EG-2940, VIDEO GASTROSCOPE
K
94
3715
VISION SYSTEM UPPER G.I. EXDOSCOPE
K
93
3717
OLYMPUS MEASURING DEVICES
K
85
0020
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
K
83
3924
TWO CHANNEL GASTROFIBERSCOPE FG-36T
K
83
2007
PENTAX FG-34JA GASTROFIBERSCOPE
FDT
Duodenoscope And Accessories, Flexible/Rigid
FDW
Esophagoscope, Rigid, Gastro-Urology
FDX
Endoscopic Cytology Brush
FDY
Device, Measuring, For Panendoscope
FDZ
Attachment, Eyepiece, For Insertion Of Prescription Lens
FEA
Attachment, Teaching, For Endoscope
FEC
Obturator, For Endoscope
FED
Endoscopic Access Overtube, Gastroenterology-Urology
FEI
Instrument, Special Lens, For Endoscope
FEJ
Attachment, Binocular, For Endoscope
FEM
Accessories, Photographic, For Endoscope (Exclude Light Sources)
FEN
Device, Cystometric, Hydraulic
FEQ
Pump, Air, Non-Manual, For Endoscope
FER
Anoscope And Accessories
FES
Recorder, External, Pressure, Amplifier & Transducer
FET
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
FFF
Cover, Biopsy Forceps
FFG
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
FFS
Image, Illumination, Fiberoptic, For Endoscope
FFT
Electrode, Ph, Stomach
FFX
System, Gastrointestinal Motility (Electrical)
FFY
Adaptor, Bulbs, Miscellaneous, For Endoscope
FFZ
Cord, Electric, For Endoscope
FGA
Kit, Nephroscope
FGB
Ureteroscope And Accessories, Flexible/Rigid
FGC
Urethroscope
FGS
Carrier, Sponge, Endoscopic
FHO
Pneumoperitoneum Needle
FHP
Needle, Pneumoperitoneum, Simple
FHX
Jelly, Lubricating, For Transurethral Surgical Instrument
FJL
Resectoscope
FTI
Lamp, Endoscope, Incandescent
FTJ
Colonoscope, General & Plastic Surgery
GCF
Proctoscope
GCK
Gastroscope, General & Plastic Surgery
GCL
Esophagoscope, General & Plastic Surgery
GCM
Endoscope, Rigid
GCN
Endoscope, Prism
GCO
Endoscope, Mirror
GCP
Endoscope, Ac-Powered And Accessories
GCQ
Endoscope, Flexible
GCS
Endoscope, Battery-Powered And Accessories
GCT
Light Source, Endoscope, Xenon Arc
GCW
Transformer, Endoscope
GDB
Endoscope, Fiber Optic
KDM
Sigmoidoscope, Rigid, Non-Electrical
KDO
Rongeur, Cystoscopic, Hot
KGD
Scissors For Cystoscope
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
KNW
Instrument, Biopsy
MNK
Endoscopic Bite Block
MNL
Accessories, Cleaning Brushes, For Endoscope
MYE
System, Electrogastrography (Egg)
NBG
Marker, Colon
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
NLM
Laparoscope, General & Plastic Surgery, Reprocessed
NLS
Instrument, Biopsy, Reprocessed
NLX
Needle, Pneumoperitoneum, Spring Loaded, Reprocessed
NMX
Needle And Needle Set, Gastro-Urology, Reprocessed
NMY
Needle, Endoscopic, Reprocessed
NON
Forceps, Biopsy, Non-Electric, Reprocessed
NSI
System, Imaging, Esophageal, Wireless, Capsule
NTN
Led Light Source
NWB
Endoscope, Accessories, Narrow Band Spectrum
NYV
Gastrointestinal Motility System, Capsule
NWS
Kit, Choledochoscope, Flexible And Rigid
NWT
Endoscopic Cholangiogram Kit
NWU
Endoscope Introducer Kit
OCS
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
OCT
Anti Fog Solution And Accessories, Endoscopy
OCU
Endoscopic Storage Cover
OCV
Endoscope Holder
OCW
Endoscopic Tissue Approximation Device
OCX
Endoscopic Irrigation/Suction System
OCY
Endoscopic Guidewire, Gastroenterology-Urology
OCZ
Endoscopic Grasping/Cutting Instrument, Non-Powered
ODA
Endoscopic Central Control Unit
ODB
Endoscopic Contamination Prevention Sheath
ODC
Endoscope Channel Accessory
ODD
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
ODE
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
ODF
Mini Endoscope, Gastroenterology-Urology
ODG
Endoscopic Ultrasound System, Gastroenterology-Urology
PCV
Endoscopic Leak Tester
PEA
Endoscope, Accessories, Image Post-Processing For Color Enhancement
PGD
Colon Capsule Imaging System
PGU
Spatial Imaging For Display Of Endoscope Position
PHT
Basin For Endoscope Reprocessing
PLL
Submucosal Injection Agent
POZ
Biopsy Needle Kit
PPE
Nephroscope Set
PRV
Gastro-Urology Biopsy Kit
PTQ
Endoscopic Magnetic Retriever, Exempt
QFZ
Gastroenterology-Urology Accessories To A Biopsy Instrument
PTR
Scissors For Cytoscope, Exempt
PTS
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
QIJ
Endoscopic Transhepatic Venous Access Needle
QIS
Esophageal, Mucosal, Electrical Characterization
QKZ
Magnetically Maneuvered Capsule Endoscopy System
QNP
Gastrointesinal Lesion Software Detection System
SBX
Software For Endoscopy Procedure Metrics
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
subpart-b—diagnostic-devices
/
FDS
/
K192704
View Source
Endofresh Digestive Endoscopy System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192704
510(k) Type
Traditional
Applicant
HuiZhou Xzing Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/2/2020
Days to Decision
341 days
Submission Type
Summary