FDA.reportPublic FDA data

Single-use Fine Needle Biopsy (FNB) Device

Primary DI
04953170459252
Brand
Single-use Fine Needle Biopsy (FNB) Device
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
NA-U210H-8022
Catalog number
N6221330
Published
2025-12-02
Public version status
Update
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
FCGBiopsy Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252646000Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.2025-10-24FCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170459259PackageGS11In Commercial Distribution
54953170459257PackageGS19Not in Commercial Distribution
04953170459252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317045925914953170459259
5495317045925754953170459257
04953170459252049531704592524953170459252

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
04953170467875THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type STB-0535FCSR50016442026-10-29
04953170467882THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSR50016452026-10-29
04953170047671VALVULOTOME (DETACHABLE TYPE)C-0103B2016-09-21
04953170047695VALVULOTOME (DETACHABLE TYPE)C-0104B2016-09-21
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21

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04953170459207Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02