FDA.reportPublic FDA data

HTx Disposable Hysteroscope

Primary DI
06974880993407
Brand
HTx Disposable Hysteroscope
Company
Suzhou AcuVu medical technology Co., Ltd.
Model
HTx40-L
Device description
Disposable hysteroscope with a working channel suitable for 5Fr tools to cut and remove uterine lesions and take a biopsy. The outer diameter of the scope is less than or equal to 4.5 mm.
Published
2025-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K231260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231260000HTx Disposable Hysteroscope SystemSuzhou AcuVu Medical Technology Co., Ltd.2024-03-05HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26974880993401PackageGS16In Commercial Distribution
06974880993407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697488099340126974880993401
06974880993407069748809934076974880993407

GMDN Terms#

Term, Definition table
TermDefinition
Rigid video hysteroscopeAn electrically-powered endoscope with a rigid inserted portion (which may have a flexible-tip) intended for visual examination and treatment of the cervix canal and uterine cavity (uterus), or for removal of an early or non-viable embryo/foetus upon connection to an abortion suction system. It is inserted through the vagina during hysteroscopy; some types are also intended for insertion into the female urethra during cystoscopy. An image sensor chip at the distal end of the device transmits the video images to a display monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or conditions related to the menstrual period (e.g., menorrhagia). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity35 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
6178344997frank.huang@sz-acuvu.com

Regulatory Flags#

DUNS number
705464292
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974880994343Omni® Hysteroscopic GrasperOMNI-G-DSI-0012026-04-17
06974880991441HTx Disposable HysteroscopeHTx60t2025-05-08
06974880991458HTx Disposable HysteroscopeHTx60-L2025-05-08
06974880993124Single action scissorsRSI-370-7-A2025-05-08
06974880993131Biopsy forcepsRSI-370-7-C2025-05-08
06974880993148Serrated forcepsRSI-370-7-D2025-05-08
06974880993155Alligator grasperRSI-370-7-E2025-05-08
06974880993162Hook grasper RSI-370-7-G2025-05-08
06974880993179Single action scissorsRSI-370-9-A2025-05-08
06974880993186Biopsy forcepsRSI-370-9-C2025-05-08
06974880993193Serrated forcepsRSI-370-9-D2025-05-08
06974880993209Alligator grasperRSI-370-9-E2025-05-08
06974880993216Hook grasper RSI-370-9-G2025-05-08
26974880991445HTx Disposable HysteroscopeHTx60t2025-05-08
26974880991452HTx Disposable HysteroscopeHTx60-L2025-05-08
06974880991632HTx Disposable HysteroscopeHTx60c2025-05-08
16974880993121Single action scissorsRSI-370-7-A2025-05-08
16974880993138Biopsy forcepsRSI-370-7-C2025-05-08
16974880993145Serrated forcepsRSI-370-7-D2025-05-08
16974880993152Alligator grasperRSI-370-7-E2025-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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