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4K UHD Laparoscope

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 4K1000LRModel 4K5500(&R),4K5530(&R),4K5545(&R),4K1000(&R),4K1030(&R),4K1045(&R),4K1000L(&LR),4K1030L(&LR),4K1045L(&LR),4K5500L(&LR)，4K5530L(&LR)，4K5545L(&LR)

by Scivita Medical Technology Co., Ltd.

Identity

Trade Name
4K UHD Laparoscope EUDAMEDFDA UDI
Generic Name
Rigid optical laparoscope FDA UDI
Device Name
4K UHD Laparoscope EUDAMED
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus. 4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter. FDA UDI
Model / Reference
4K5500(&R),4K5530(&R),4K5545(&R),4K1000(&R),4K1030(&R),4K1045(&R),4K1000L(&LR),4K1030L(&LR),4K1045L(&LR),4K5500L(&LR)，4K5530L(&LR)，4K5545L(&LR) EUDAMED
4K1000LR EUDAMEDFDA UDI
Description
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus. 4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter. FDA UDI

Identifiers

Primary DI / UDI-DI
06971381251388 EUDAMEDFDA UDI
Basic UDI-DI
697138125004A88 EUDAMED
Direct Marketing DI
06971381251388 EUDAMED
510(k) Number
K221252 FDA UDI
FDA Product Code
GCJ FDA UDI
IZI FDA UDI
EMDN Code
Z12029009 LAPAROSCOPES EUDAMED
GMDN Term
Rigid optical laparoscope FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
892.1600 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

4K UHD Laparoscope by Scivita Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Scivita Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000010305
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (3)

  • EUDAMED a37d9a3e-bbff-4ea4-9707-aa01758096aa 61 fields · synced Jul 27, 2026
  • FDA UDI 3795e8b7-9c28-45d1-b7e9-fa43bda3e94d 35 fields · synced May 29, 2026
  • FDA 510(k) K203255 1 fields · synced May 18, 2026