Brush, Biopsy, Bronchoscope (Non-Rigid)
The Brush, Biopsy, Bronchoscope (Non-Rigid) is a device passed through a flexible bronchoscope to collect cellular material from airway surfaces or lesions by brushing, for cytological analysis. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTG, regulated under 21 CFR 874.4680 in the Ear, Nose, and Throat specialty. This device is eligible for third-party review. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission, as required by 82 FR 26807.
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Basic Information
- Product Code
- BTG
- Device Class
- FDA class 2
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251279 | Disposable Cytology Brush BC-202D/203D Series | Jun 12, 2025 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K182927 | Pulmonary Cytology Brush | Feb 07, 2020 | Substantially Equivalent | Hobbs Medical, Inc. |
| K190293 | Single Use Cytology Brush BC-205D | Aug 02, 2019 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K130357 | SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH | Nov 06, 2013 | Substantially Equivalent | Covidien, LLC |
| K820771 | MICROBIOLOGY SPECIMEN BRUSH | May 03, 1982 | Substantially Equivalent | Mill-Rose Laboratory |
| K780872 | CYTOLOGY BRUSH | Sep 07, 1978 | Substantially Equivalent | CooperVision, Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.