FDA.reportPublic FDA data

DISPOSABLE DISTAL ATTACHMENT

Primary DI
14953170454322
Brand
DISPOSABLE DISTAL ATTACHMENT
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
D-201-12704
Catalog number
N3529241
Published
2025-05-12
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

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250296000Disposable Distal Attachment D-201 SeriesOlympus Medical Systems Corp.2025-05-01FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170454322PackageGS110In Commercial Distribution
04953170454325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317045432214953170454322
04953170454325049531704543254953170454325

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope distal observation spacer, single-useA short, light-penetrating cap designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation, by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap; it does not have anchoring capabilities (i.e., not an anchoring cuff). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410566253FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDS2026-02-27
04547410477153FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04547410513790FUJIFILMFUJIFILM CORPORATIONFDS2025-05-31
04953170425103COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-26
04953170425158COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2025-05-26
04547410532876FUJIFILMFUJIFILM CORPORATIONFDS2024-12-20
04547410500646FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
04547410528268FUJIFILMFUJIFILM CORPORATIONFDS2024-09-20
00850006222322Pathfinder® CR SystemNEPTUNE MEDICAL INC.FDS2024-07-09
14961333079343PENTAXHOYA CORPORATIONFDS2023-07-31
14961333085535PENTAXHOYA CORPORATIONFDS2023-07-31
04953170414596EVIS X1 VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
0495317041560912G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
0495317041562312G-SDI cableOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
0495317041563012G-SDI cable 8.5MOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
049531704156473G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170415654Foot holderOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170415685Footswitch Conversion cableOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170420191GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170424281COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170424298COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-07-04
04953170453823DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29
04953170453830DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29
04953170453847DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29
04953170453854DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDS2023-04-29