FDA.reportPublic FDA data

ClearVision

Primary DI
06976860690399
Brand
ClearVision
Company
OriGyn Medical Technology (Hangzhou) Co., Ltd.
Model
EHS-Op5001
Device description
ClearVision Single Use Hysteroscope
Published
2024-09-23
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

Product Codes#

Code, Name table
CodeName
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240401000ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)Origyn Medical Technology (Hangzhou) Co., Ltd.2024-07-26HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16976860690051PackageGS15In Commercial Distribution
06976860690399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697686069005116976860690051
06976860690399069768606903996976860690399

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413121050
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
06976860690412OriGynMEDYZ211.0412025-08-28
06976860690429OriGynMEDYZ211.0422025-08-28
06976860690436OriGynMEDYZ211.0432025-08-28
06976860690443OriGynMEDYZ211.0442025-08-28
06976860690450OriGynMEDYZ211.0452025-08-28
06976860690467OriGynMEDYZ211.0462025-08-28
06976860690474OriGynMEDYZ211.0472025-08-28
06976860690481OriGynMEDYZ211.0812025-08-28
06976860690498OriGynMEDYZ211.0822025-08-28
06976860690504OriGynMEDYZ211.0832025-08-28
06976860690511OriGynMEDYZ211.0842025-08-28
06976860690528OriGynMEDYZ211.0852025-08-28
06976860690535OriGynMEDYZ211.0862025-08-28
06976860690542OriGynMEDYZ211.0872025-08-28
06976860690559OriGynMEDYZ211.0512025-08-28
06976860690566OriGynMEDYZ211.0522025-08-28
06976860690573OriGynMEDYZ211.0532025-08-28
06976860690580OriGynMEDYZ211.0542025-08-28
06976860690597OriGynMEDYZ211.0552025-08-28
06976860690603OriGynMEDYZ211.0562025-08-28

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Primary DI, Brand, Company table
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B382SD80055210Surgical DirectSurgical Direct, Inc.HIN2026-02-12
00842180135437ELMED INCORPORATEDELMED INCORPORATEDHIN2025-09-29
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00198506020841ELMED INCORPORATEDELMED INCORPORATEDHIN2025-03-05
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06976860690382ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690405ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
00887482128596Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HIN2024-09-09
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00198506060731ELMED INCORPORATEDELMED INCORPORATEDHIN2024-08-26
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00842180172012ELMEDELMED INCORPORATEDHIN2023-06-20