FDA.reportPublic FDA data

Jiyuan

Primary DI
06973672290038
Brand
Jiyuan
Company
Jiangsu Jiyuan Medical Technology Co .,Ltd.
Model
JY-MIP-1000
Device description
CVBS/HDMI, ARMI, Image processor for medical endoscope
Published
2022-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210270000Medical Endoscope Image Processing SystemJiangsu Jiyuan Medical Technology Co., Ltd.2021-10-01HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973672290038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973672290038069736722900386973672290038

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic control/video-imaging systemA mains electricity (AC-powered) multifunctional device assembly designed to interface with a flexible steerable, self-propelled, or externally-propelled video endoscope (not included) to: 1) control movement of the endoscope (e.g., steer, propel); and 2) receive and process electronic video image signals sent from the endoscope. It includes a controller/control unit, image processor, and may include an image display monitor and light source. It might additionally allow control of insufflation or suction.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
414764719
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973672291158ARMISH-02A2026-01-23
06973672291165ARMISH-03A2026-01-23
06973672291172ARMISH-02B2026-01-23
06973672291189ARMISH-03C2026-01-23
16973672291155ARMISH-02A2026-01-23
16973672291162ARMISH-03A2026-01-23
16973672291179ARMISH-02B2026-01-23
16973672291186ARMISH-03C2026-01-23
06973672291196ARMIJY-MIP-30002026-01-23
06973672291066JiyuanJY-CC-450-15-S2025-08-12
16973672291063JiyuanJY-CC-450-15-S2025-08-12
06973672291059JiyuanJY-CC-350-12-S2025-07-31
16973672291056JiyuanJY-CC-350-12-S2025-07-31
06973672290793JiyuanJY-CC-450-18-S2025-01-13
16973672290790JiyuanJY-CC-450-18-S2025-01-13
06973672290410WiScopeOTU-HJ012024-03-11
06973672290007JiyuanJY-DEH-0012022-02-17
06973672290014JiyuanJY-DEH-0022022-02-09
06973672290021JiyuanJY-DEH-0032022-02-09
16973672290004JiyuanJY-DEH-0012022-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
08714729986935Cytuity™BOSTON SCIENTIFIC CORPORATIONHIH2019-08-20
10884521750203TruClearCovidien LPHIH2018-12-21
00821925004986Gyrus ACMIGyrus ACMI, LLCHIH2018-09-13
10884521744080TruClearCovidien LPHIH2017-10-16
10884521744097TruClearCovidien LPHIH2017-10-16
10884521744103TruClearCovidien LPHIH2017-10-16
10884521744110TruClearCovidien LPHIH2017-10-16
M648C0100110SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN OBP CORPORATIONHIH2016-11-11
M648C0100120 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO OBP CORPORATIONHIH2016-11-11
00821925001862USA SeriesGyrus ACMI, LLCHIH2016-10-14