FDA.reportPublic FDA data

Manual Tissue Removal Device

Primary DI
06974880994053
Brand
Manual Tissue Removal Device
Company
Suzhou AcuVu medical technology Co., Ltd.
Model
MTRD-9-325
Device description
AcuVu’s MTRD system consists of a cutting window, blade, shaft, rotation knob, tissue trap and cover, handle, trigger and outflow tube. In addition, a configurable vacuum source is required to absorb the cut tissue from the outflow tube.
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K254050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254050000Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.2026-05-15HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26974880994057PackageGS15In Commercial Distribution
06974880994053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697488099405726974880994057
06974880994053069748809940536974880994053

GMDN Terms#

Term, Definition table
TermDefinition
Hysteroscopic resection deviceA sterile, hand-held, manual surgical instrument intended to be inserted through the working channel of a hysteroscope to cut and remove uterine lesions (e.g., polyps), and may in addition be used to obtain a mucosal biopsy. It consists of a distal cannula with a side-notch and internal oscillating cutting blade, a proximal handle/operating mechanism, and may include a suction port; it does not have a snare mechanism and is not an electrosurgical device. This is a single-use device.

Regulatory Flags#

DUNS number
705464292
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
06974880994084Manual Tissue Removal DeviceMTRD-9-3702026-07-27
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
06974880993407HTx Disposable HysteroscopeHTx40-L2025-05-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
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
14042761085172OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085189OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085196OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085202OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085219OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085226OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085233OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085240OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085257OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085264OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085271OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085288OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085295OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085301OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31