FDA Product Code
FDA Product Code KTI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4680
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | Cook Ireland, Ltd. | 2026-07-24 | Traditional | PDF ↗ |
| K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | 2026-04-16 | Traditional | PDF ↗ |
| K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | 2026-03-12 | Traditional | PDF ↗ |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | 2025-10-08 | Special | PDF ↗ |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | Olympus Medical Systems Corporation | 2025-07-29 | Traditional | PDF ↗ |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | 2025-03-31 | Traditional | PDF ↗ |
| K241679 | Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-03-04 | Traditional | PDF ↗ |
| K231818 | METIC- Airway Balloon Catheter | M/S Meril Life Sciences Pvt. , Ltd. | 2023-11-15 | Traditional | PDF ↗ |
| K230778 | EndoCore | Praxis Medical, LLC | 2023-09-25 | Traditional | PDF ↗ |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | Ga Health Company Limited | 2023-05-11 | Traditional | PDF ↗ |
| K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023-03-01 | Traditional | PDF ↗ |
| K221206 | Compass Steerable Needle | Serpex Medical, Inc. | 2022-08-25 | Traditional | PDF ↗ |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-20 | Traditional | PDF ↗ |
| K213434 | Elation Pulmonary Balloon Dilation Catheter | Merit Medical Systems, Inc. | 2022-03-08 | Traditional | PDF ↗ |
| K211894 | Trachealator | Disa Medinotec | 2021-11-24 | Traditional | PDF ↗ |
| K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2020-03-18 | Traditional | PDF ↗ |
| K190239 | Single Use Aspiration Needle | Olympus Medical Systems Corp. | 2019-12-10 | Traditional | PDF ↗ |
| K181193 | PeriView FLEX | Olympus Surgical Technologies America | 2018-07-03 | Special | PDF ↗ |
| K171232 | PeriView FLEX | Olympus Surgical Technologies America | 2017-09-21 | Traditional | PDF ↗ |
| K170759 | CRE Pulmonary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017-06-23 | Special | PDF ↗ |
| K163469 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2017-04-06 | Traditional | PDF ↗ |
| K161392 | Elation Pulmonary Balloon Dilation | Merit Medical Systems, Inc. | 2016-09-01 | Traditional | PDF ↗ |
| K153484 | Dillard Airway Dilatation System | Intuit Medical Products, LLC | 2016-07-27 | Traditional | PDF ↗ |
| K152922 | ViziShot FLEX | Spiration, Inc. | 2016-02-19 | Traditional | PDF ↗ |
| K151522 | DEFENDO Bronchoscopy Suction Valve | Medivators, Inc. | 2015-09-17 | Traditional | PDF ↗ |
| K150951 | aeris Balloon Dialation Catheter | Bryan Medical, Inc. | 2015-06-25 | Traditional | PDF ↗ |
| K110218 | INSPIRA AIR BALLOON DILATION SYSTEM | Acclarent, Inc. | 2011-03-31 | Special | PDF ↗ |
| K090660 | AIRWAY BALLOON CATHETER INFLATION DEVICE | Acclarent, Inc. | 2009-06-12 | Traditional | PDF ↗ |
| K082174 | Y-ADAPTER | Asthmatx, Inc. | 2008-10-20 | Traditional | PDF ↗ |
| K023337 | CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 | Boston Scientific Corp | 2002-11-18 | Traditional | PDF ↗ |
| K020765 | MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 | Boston Scientific Corp | 2002-04-05 | Traditional | PDF ↗ |
| K833491 | ENDO BITE BLOCK | American Endoscopy, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K781365 | SPARTA BRONCHIAL BRUSH | Sparta Instrument Corp. | 1978-08-14 | Traditional | PDF ↗ |
Product code KTI · Class II · Ear, Nose, Throat. Data: openFDA.