FDA.report

Zenflow Spring® Scope

Primary DI
00850081334033
Brand
Zenflow Spring® Scope
Company
ZENFLOW, INC.
Model
ZFS-SCP-01
Catalog number
ZFS-SCP-01
Published
2026-05-22
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

Related Records

Contact Domains

Product Codes

CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K251140000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251140000Zenflow Spring ScopeZenflow, Inc.2025-09-23FAJ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850081334033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850081334033008500813340338500813340330850081334033

GMDN Terms

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.

Contacts

PhoneEmail
650-419-7557info@zenflow.com

Regulatory Flags

DUNS number
079412969
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
false
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 DIBrandModelCatalogPublished
00850081334002Zenflow Spring® Implant and Delivery SystemZFS-IMP-15-01ZFS-IMP-15-012026-05-22
00850081334019Zenflow Spring® Implant and Delivery SystemZFS-IMP-18-01ZFS-IMP-18-012026-05-22
00850081334026Zenflow Spring® Implant and Delivery SystemZFS-IMP-21-01ZFS-IMP-21-012026-05-22
00850081334040Zenflow Spring® Implant Retrieval DeviceZFS-IRD-01ZFS-IRD-012026-05-22
00850081334057Zenflow Camera Control UnitZFS-CCU-01ZFS-CCU-012026-05-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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