KTI — Bronchoscope Accessory Class II
FDA product code KTI covers "Bronchoscope Accessory", a Class II medical device regulated under 21 CFR 874.4680. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K251478 | finemedix co | ClearTip TBNA Type | April 16, 2026 |
| 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 |