FUJIFILM Stiffening Wire (SW-2000)

Primary DI
00860014745003
Brand
FUJIFILM Stiffening Wire (SW-2000)
Company
Fujifilm Healthcare Americas Corporation
Model
SW-2000
Published
2025-12-18
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
FDAEnteroscope And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251204000FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation2025-09-26FDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014745003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014745003008600147450038600147450030860014745003

GMDN Terms#

Term, Definition table
TermDefinition
Colonoscope stiffenerA dedicated stiff wire that is inserted into a flexible colonoscope to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required during a colonoscopy. This is a reusable device.

Regulatory Flags#

DUNS number
041767039
Device count
1
Lot or batch
true

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