BTG · Brush, Biopsy, Bronchoscope (Non-Rigid)
Ear, Nose, Throat · 21 CFR 874.4680 · Class 2
Overview
| Product Code | BTG |
|---|---|
| Device Name | Brush, Biopsy, Bronchoscope (Non-Rigid) |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
Classification Rationale
Class II.
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251279 | Disposable Cytology Brush BC-202D/203D Series | Olympus Medical Systems Corporation | Jun 12, 2025 | SESE |
| K182927 | Pulmonary Cytology Brush | Hobbs Medical, Inc. | Feb 7, 2020 | SESE |
| K190293 | Single Use Cytology Brush BC-205D | Olympus Medical Systems Corp. | Aug 2, 2019 | SESE |
| K130357 | SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH | Covidien, LLC | Nov 6, 2013 | SESE |
| K820771 | MICROBIOLOGY SPECIMEN BRUSH | Mill-Rose Laboratory | May 3, 1982 | SESE |
| K780872 | CYTOLOGY BRUSH | CooperVision, Inc. | Sep 7, 1978 | SESE |
Top Applicants
- Olympus Medical Systems Corporation — 1 clearance
- Olympus Medical Systems Corp. — 1 clearance
- Mill-Rose Laboratory — 1 clearance
- Hobbs Medical, Inc. — 1 clearance
- Covidien, LLC — 1 clearance
