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510(k) K190293

Device
Single Use Cytology Brush BC-205D
Applicant
Olympus Medical Systems Corp.
510(k) number
K190293
Product code
BTG  
Decision
Substantially Equivalent (SESE)
Decision date
2019-08-02
Date received
2019-02-11
Regulation
874.4680
Classification name
Brush, Biopsy, Bronchoscope (non-rigid)
Medical specialty
Ear Nose & Throat
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Toshiyuki Nakajima
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
K251279Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation2025-06-12
K182927Pulmonary Cytology BrushHobbs Medical, Inc.2020-02-07
K130357SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSHCovidien, LLC2013-11-06
K820771MICROBIOLOGY SPECIMEN BRUSHMill-Rose Laboratory1982-05-03
K780872CYTOLOGY BRUSHCooperVision, Inc.1978-09-07

Legacy Summary#

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FDA Review#

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