FDA.reportPublic FDA data

Ascend™ Single-Use Flexible Cysto-Nephroscope HD

Primary DI
06972520302909
Brand
Ascend™ Single-Use Flexible Cysto-Nephroscope HD
Company
Guangzhou Red Pine Medical Instrument Co., Ltd.
Model
ASUS-HD-15S-CYS
Published
2025-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
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
K252176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252176000Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd.2025-08-08FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972520302909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972520302909069725203029096972520302909

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystonephroscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, urethra (including prostate region), and kidneys. It is inserted into the urethra via the natural urinary orifice, or percutaneously into the renal pelvis for the kidneys during endoscopy. Anatomical images are obtained via a camera incorporated at its distal end and are shown on a monitor. It is typically used for the removal/crushing of stones, investigation of pyelitis and renal failure, treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
417649868
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972520300677Endoscopic Video Image ProcessorRP-IPD-V1000F2025-12-31
06972520301001REDPINERP-G-C242024-08-03
06972520301018REDPINERP-G-C01012024-08-03
06972520301216Ascend™ Single-Use Flexible UreteroscopeASUS-86-900R2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeASUS-86-300R2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeASUS-86-300S2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeASUS-86-900S2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeASUS-86-900R-DC2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeASUS-86-300R-DC2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeASUS-86-300S-DC2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeASUS-86-900S-DC2026-03-17
06972520301759Single-Use Video Flexible UreterorenoscopeRP-U-C03R92025-12-31
06972520301766Single-Use Video Flexible UreterorenoscopeRP-U-C03S92025-12-31
06972520301773Single-Use Video Flexible UreterorenoscopeRP-U-C03R32025-12-31
06972520301780Single-Use Video Flexible UreterorenoscopeRP-U-C03S32025-12-31
06972520302794Ascend™ Single-Use Flexible UreteroscopeASUS-75-900R2025-12-31
06972520302800Ascend™ Single-Use Flexible UreteroscopeASUS-75-900S2025-12-31
06972520302817Ascend™ Single-Use Flexible UreteroscopeASUS-75-300R2025-12-31
06972520302824Ascend™ Single-Use Flexible UreteroscopeASUS-75-300S2025-12-31
06972520302893Ascend™ Single-Use Flexible Cysto-Nephroscope HDASUS-HD-15R-CYS2025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893144Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893151Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893168Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893175Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893182Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893199Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893205Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893212Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893229Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893236Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893243Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893250Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893267Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893274Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893281Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893298Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893304Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893311Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00848657076609AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076616AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076623AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078412AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078429AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078436AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078443AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085656AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085663AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00810143893007Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-20