FDA.reportPublic FDA data

DeepEye

Primary DI
06972304750414
Brand
DeepEye
Company
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Model
EVS200
Device description
Video Endoscopy processor
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FGBUreteroscope And Accessories, Flexible/Rigid
GCJLaparoscope, General & Plastic Surgery
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210116000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210116000Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.2021-10-13HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972304750414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972304750414069723047504146972304750414

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Regulatory Flags#

DUNS number
550274579
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972304750407DeepEyeEVS1002026-05-22
06972304750834DophiNPG30002026-05-22
06972304751404InflaCureGVS1002026-05-22
16972304750381DeepEyeLPS210002026-05-22
16972304750398DeepEyeLPS210302026-05-22
16972304750428DeepEyeLPS310002026-05-22
16972304750435DeepEyeLPS310302026-05-22
16972304750770DophiNSP132026-05-22
16972304750787DophiNSP182026-05-22
16972304750794DophiNSP252026-05-22
16972304750800DophiNTP132026-05-22
16972304750817DophiNTP182026-05-22
16972304750824DophiNTP252026-05-22
16972304750848DophiNFS062026-05-22
16972304751555InflaCureGI-S0012026-05-22
16972304750015DophiSS-TP18G-202022-01-19
06972304750209DophiR150E2022-03-07
06972304751411DophiSJ-A012022-03-07
16972304750022DophiSS-RFAS1-15102022-03-07
16972304750039DophiSS-RFAS1-15202022-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
00817401029185EndoplusEndoplusHET2026-10-16
00817401029192EndoplusEndoplusHET2026-10-16
00817401029208EndoplusEndoplusHET2026-10-16
00817401029215EndoplusEndoplusHET2026-10-16
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434830MillenniumAvalign Technologies, Inc.HET2026-10-13
00190776434847MillenniumAvalign Technologies, Inc.HET2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
06936345105749Single-Use Digital Flexible UreteroscopeDongguan ZSR Biomedical Technology Company LimitedFGB2026-10-10
06936345105756Single-Use Digital Flexible UreteroscopeDongguan ZSR Biomedical Technology Company LimitedFGB2026-10-10
06936345110002Single-Use Digital Flexible UreteroscopeDongguan ZSR Biomedical Technology Company LimitedFGB2026-10-10
06936345110026Single-Use Digital Flexible UreteroscopeDongguan ZSR Biomedical Technology Company LimitedFGB2026-10-10
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09