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510(k) K251279

Device
Disposable Cytology Brush BC-202D/203D Series
Applicant
Olympus Medical Systems Corporation
510(k) number
K251279
Product code
BTG
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-12
Date received
2025-04-24
Regulation
874.4680
Classification name
Brush, Biopsy, Bronchoscope (Non-Rigid)
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Seiko Yunoki
Address
2951 Ishikawa-Cho Hachioji-Shi JP 192-8507 192-8507

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BTG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182927Pulmonary Cytology BrushHobbs Medical, Inc.2020-02-07
K190293Single Use Cytology Brush BC-205DOlympus Medical Systems Corp.2019-08-02
K130357SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSHCovidien, LLC2013-11-06
K820771MICROBIOLOGY SPECIMEN BRUSHMill-Rose Laboratory1982-05-03
K780872CYTOLOGY BRUSHCooperVision, Inc.1978-09-07