FDA.reportPublic FDA data

Single Use Flexible Video Cystoscope

Primary DI
06971176280357
Brand
Single Use Flexible Video Cystoscope
Company
Zhuhai Pusen Medical Technology Co, Ltd
Model
PC200-R
Device description
This device is a sterile, single use video cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Single Use Flexible Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories.
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222602000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222602000Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)Zhuhai Pusen Medical Technology Co., Ltd.2022-09-26FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971176280354PackageGS110In Commercial Distribution
06971176280357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697117628035416971176280354
06971176280357069711762803576971176280357

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, single-useA sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544427443
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971176281729EviewPV3002026-01-22
06971176281965EviewPVX8002026-01-22
06971176282399EviewPV2202026-01-22
06971176283570Foot Switch (HRF-M5 PS)HRF-M5 PS2026-01-22
06971176282924Single Use Video Ureteroscope Direct In-Scope SuctionPU630A-S2026-01-13
06971176282931Single Use Video Ureteroscope Direct In-Scope SuctionPU630A-R2026-01-13
06971176282955Single Use Flexible Video UreteroscopePU631A-R2026-01-13
06971176282962Single Use Video Ureteroscope Direct In-Scope SuctionPU632A-S2026-01-13
06971176282986Single Use Flexible Video UreteroscopePU633A-S2026-01-13
06971176282993Single Use Flexible Video UreteroscopePU633A-R2026-01-13
16971176282921Single Use Video Ureteroscope Direct In-Scope SuctionPU630A-S2026-01-13
16971176282938Single Use Video Ureteroscope Direct In-Scope SuctionPU630A-R2026-01-13
06971176282948Single Use Flexible Video UreteroscopePU631A-S2026-01-13
16971176282952Single Use Flexible Video UreteroscopePU631A-R2026-01-13
16971176282969Single Use Video Ureteroscope Direct In-Scope SuctionPU632A-S2026-01-13
06971176282979Single Use Video Ureteroscope Direct In-Scope SuctionPU632A-R2026-01-13
16971176282983Single Use Flexible Video UreteroscopePU633A-S2026-01-13
16971176282990Single Use Flexible Video UreteroscopePU633A-R2026-01-13
06971176281828Single Use Video Ureteroscope Direct In-Scope SuctionPU3033AH-S2025-10-17
06971176281835Single Use Video Ureteroscope Direct In-Scope SuctionPU3033AH-R2025-10-17

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Primary DI, Brand, Company table
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06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
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