FDA.reportPublic FDA data

NA

Primary DI
06959664922323
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
UW600-III
Published
2025-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241704000Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.2025-03-20OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06959664922323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06959664922323069596649223236959664922323

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation pumpAn electrically-powered device, which may include noninvasive accessories, intended to pump a sterile fluid (e.g., saline water) to irrigate body cavities/wounds during surgery (e.g., general surgery, endoscopic). It is typically intended to be used to wash away tissues/fluids/debris with a sterile fluid to facilitate observation; it is not intended to administer parenteral fluids or drugs and is not capable of suction. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542984702
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664944677NAAG-5033-14162026-08-21
06959664900086NAAG-51061-1650-090-92026-08-19
06959664900178NAAG-51061-1800-090-92026-08-19
06959664900185NAAG-51061-1950-090-92026-08-19
06959664900192NAAG-51061-2150-090-92026-08-19
06959664900291NAAG-51061-2300-090-92026-08-19
06959664900307NAAG-51061-1650-135-92026-08-19
06959664900314NAAG-51061-1800-135-92026-08-19
06959664900543NAAG-51061-1950-135-92026-08-19
06959664900550NAAG-51061-2150-135-92026-08-19
06959664900574NAAG-51061-2300-135-92026-08-19
06959664900598NAAG-51063-1650-090-132026-08-19
06959664900635NAAG-51063-1800-090-132026-08-19
06959664900666NAAG-51063-1950-090-132026-08-19
06959664900697NAAG-51063-1950-090-132026-08-19
06959664900840NAAG-51063-1950-090-132026-08-19
06959664900864NAAG-51063-1650-135-132026-08-19
06959664900871NAAG-51063-1800-135-132026-08-19
06959664900888NAAG-51063-1950-135-132026-08-19
06959664900895NAAG-51063-2150-135-132026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONOCX2026-08-25
00884450457535C2 CryoBalloon™Merit Medical Systems, Inc.OCX2026-08-17
B382SD20260Surgical DirectSurgical Direct, Inc.OCX2026-08-03
08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356157ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356171ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
04953170465277AUXILIARY WATER TUBEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-12-05
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.OCX2025-10-10
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
00850025860901CO2 Source Tubing Filter Adapter OlympusMicro-tech UsaOCX2025-05-12
00858276007977CO2 Source Tubing Filter OlympusMicro-tech UsaOCX2025-05-12
00850025860420Irrigation Tubing SetMicro-tech UsaOCX2025-03-07
00850025860390Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860451Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860772Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860789Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860796Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860840Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860307A/W Channel Cleaning Adapter + 4-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258603694-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258605813-Piece Valve KitMicro-tech UsaOCX2025-03-03
00858276007243Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
00858276007335Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10