KTI · Bronchoscope Accessory
Ear, Nose, Throat · 21 CFR 874.4680 · Class 2
Overview
| Product Code | KTI |
|---|---|
| Device Name | Bronchoscope Accessory |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
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 (33)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | Apr 16, 2026 | SESE |
| K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | Mar 12, 2026 | SESE |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | Dec 19, 2025 | SESE |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | Oct 8, 2025 | SESE |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | Olympus Medical Systems Corporation | Jul 29, 2025 | SESE |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | Mar 31, 2025 | SESE |
| K241679 | Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | Mar 4, 2025 | SESE |
| K231818 | METIC- Airway Balloon Catheter | M/S Meril Life Sciences Pvt. , Ltd. | Nov 15, 2023 | SESE |
| K230778 | EndoCore | Praxis Medical, LLC | Sep 25, 2023 | SESE |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | Ga Health Company Limited | May 11, 2023 | SESE |
| K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | Mar 1, 2023 | SESE |
| K221206 | Compass Steerable Needle | Serpex Medical, Inc. | Aug 25, 2022 | SESE |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | Jul 20, 2022 | SESE |
| K213434 | Elation Pulmonary Balloon Dilation Catheter | Merit Medical Systems, Inc. | Mar 8, 2022 | SESE |
| K211894 | Trachealator | Disa Medinotec | Nov 24, 2021 | SESE |
| K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | Mar 18, 2020 | SESE |
| K190239 | Single Use Aspiration Needle | Olympus Medical Systems Corp. | Dec 10, 2019 | SESE |
| K181193 | PeriView FLEX | Olympus Surgical Technologies America | Jul 3, 2018 | SESE |
| K171232 | PeriView FLEX | Olympus Surgical Technologies America | Sep 21, 2017 | SESE |
| K170759 | CRE Pulmonary Balloon Dilatation Catheter | Boston Scientific Corporation | Jun 23, 2017 | SESE |
| K163469 | ViziShot 2 FLEX | Olympus Surgical Technologies America | Apr 6, 2017 | SESE |
| K161392 | Elation Pulmonary Balloon Dilation | Merit Medical Systems, Inc. | Sep 1, 2016 | SESE |
| K153484 | Dillard Airway Dilatation System | Intuit Medical Products, LLC | Jul 27, 2016 | SESE |
| K152922 | ViziShot FLEX | Spiration, Inc. | Feb 19, 2016 | SESE |
| K151522 | DEFENDO Bronchoscopy Suction Valve | Medivators, Inc. | Sep 17, 2015 | SESE |
| K150951 | aeris Balloon Dialation Catheter | Bryan Medical, Inc. | Jun 25, 2015 | SESE |
| K110218 | INSPIRA AIR BALLOON DILATION SYSTEM | Acclarent, Inc. | Mar 31, 2011 | SESE |
| K090660 | AIRWAY BALLOON CATHETER INFLATION DEVICE | Acclarent, Inc. | Jun 12, 2009 | SESE |
| K082174 | Y-ADAPTER | Asthmatx, Inc. | Oct 20, 2008 | SESE |
| K023337 | CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 | Boston Scientific Corp | Nov 18, 2002 | SESE |
| K020765 | MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 | Boston Scientific Corp | Apr 5, 2002 | SESE |
| K833491 | ENDO BITE BLOCK | American Endoscopy, Inc. | Apr 25, 1984 | SESE |
| K781365 | SPARTA BRONCHIAL BRUSH | Sparta Instrument Corp. | Aug 14, 1978 | SESE |
Top Applicants
- Olympus Surgical Technologies America — 4 clearances
- Serpex Medical, Inc. — 2 clearances
- Olympus Medical Systems Corp. — 2 clearances
- Merit Medical Systems, Inc. — 2 clearances
- Boston Scientific Corp — 2 clearances
