FDA.report

DeepEye

Primary DI
16972304750428
Brand
DeepEye
Company
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Model
LPS31000
Device description
Video Endoscope
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

Related Records

Product Codes

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

Product Code Classifications

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

Premarket Submissions

SubmissionSupplement
K210116000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16972304750428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1697230475042816972304750428

GMDN Terms

TermDefinition
Rigid video laparoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
550274579
Device count
1
DM exempt
true
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06972304750407DeepEyeEVS1002026-05-22
06972304750414DeepEyeEVS2002026-05-22
06972304750834DophiNPG30002026-05-22
06972304751404InflaCureGVS1002026-05-22
16972304750381DeepEyeLPS210002026-05-22
16972304750398DeepEyeLPS210302026-05-22
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
06972304750667VaricureSC300ES2022-10-27
06972304750681VaricureSC200ES2022-10-27
06972304750698VaricureSC100ES2022-10-27
06972304750704VaricureES1002022-10-27
06972304750711VaricureES2002022-10-27

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06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
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16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
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