KTI — Bronchoscope Accessory Class II
Classification Details
- Product Code
- KTI
- Device Class
- Class II
- Regulation Number
- 874.4680
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254040 | free flow medical | LungFlow Basket Catheter | March 12, 2026 |
| K251402 | leadoptik | LIA-1 Catheter (542-1) | December 19, 2025 |
| K252874 | serpex medical | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | October 8, 2025 |
| K251664 | olympus medical systems corporation | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA | July 29, 2025 |
| K250263 | olympus medical systems | Disposable Grasping Forceps FG-52D/FG-54D | March 31, 2025 |
| K241679 | alton (shanghai) medical instruments co | Disposable Cytology Brush (AF series) | March 4, 2025 |
| K231818 | m/s meril life sciences pvt. | METIC- Airway Balloon Catheter | November 15, 2023 |
| K230778 | praxis medical | EndoCore | September 25, 2023 |
| K230280 | ga health company limited | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | May 11, 2023 |
| K222187 | dongguan tt medical | Multistage Balloon Dilatation Catheter | March 1, 2023 |
| K221206 | serpex medical | Compass Steerable Needle | August 25, 2022 |
| K213060 | micro-tech (nanjing) co | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultr | July 20, 2022 |
| K213434 | merit medical systems | Elation Pulmonary Balloon Dilation Catheter | March 8, 2022 |
| K211894 | disa medinotec | Trachealator | November 24, 2021 |
| K193517 | olympus surgical technologies america | ViziShot 2 FLEX | March 18, 2020 |
| K190239 | olympus medical systems | Single Use Aspiration Needle | December 10, 2019 |
| K181193 | olympus surgical technologies america | PeriView FLEX | July 3, 2018 |
| K171232 | olympus surgical technologies america | PeriView FLEX | September 21, 2017 |
| K170759 | boston scientific corporation | CRE Pulmonary Balloon Dilatation Catheter | June 23, 2017 |
| K163469 | olympus surgical technologies america | ViziShot 2 FLEX | April 6, 2017 |