LungVision Tool
510(k) K172955
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK172955 | Date26 Apr 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K172955 decided 26 Apr 2018 Active
- EUDAMED Active
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- EOQ
- FDA applicant
- Bodyvision Medical , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 874.4680
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The LungVision Tool is a working channel device designed for use within the respiratory system. It serves as an interface to guide endotherapy accessories or ultrasound probes during bronchoscopic procedures, facilitating precise navigation to target areas in the lungs.
This device is intended for single-use and is compatible with standard bronchoscopes and Olympus Bronchoscope BF-1TH190. It is supplied sterile and is regulated under FDA 510K clearance (K172955) and MDR authorisation. The product code assigned is EOQ, categorised under the Ear, Nose, and Throat advisory committee classification.
Devices cleared under K172955
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| LungVision SmartWire Bridge | LV2055050 / Bridge | 07290017652191 | — | No longer on the market |
| LungVision Tool Bridge | LV2055000 / Bridge | 07290017652016 | — | On the market |
| LungVision Tool Bridge | LV2055001 / Bridge | 07290017652023 | — | On the market |
| LungVision Tool Bridge | LV2055003 / Bridge | 07290017652047 | — | On the market |
| LungVision Tool Bridge | LV2055004 / Bridge | 07290017652061 | — | On the market |
| LungVision Tool Bridge | LV2055005 / Bridge | 07290017652078 | — | On the market |
| LungVision Tool Bridge | LV2055010 / Bridge | 07290017652092 | — | On the market |
| LungVision Tool Bridge | LV2055011 / Bridge | 07290017652108 | — | On the market |
| LungVision Tool Bridge | LV2055020 / Bridge | 07290017652115 | — | On the market |
| LungVision Tool Bridge | LV2055021 / Bridge | 07290017652122 | — | On the market |
| LungVision Tool Bridge | LV2055030 / Bridge | 07290017652139 | — | No longer on the market |
| LungVision Tool Bridge | LV2055031 / Bridge | 07290017652146 | — | No longer on the market |
| LungVision Tool Bridge | LV2055040 / Bridge | 07290017652153 | — | No longer on the market |
| LungVision Tool Bridge | LV2055041 / Bridge | 07290017652160 | — | No longer on the market |
| LungVision Tool Bridge | LV2055042 / Bridge | 07290017652177 | — | No longer on the market |
| LungVision Tool Bridge | LV2055043 / Bridge | 07290017652184 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).
- FUJIFILM Bronchoscope Model EB-530P by Fujifilm Medical System U.S.A., Inc.
- PlanPoint 380718 by Intuitive Surgical, Inc.
- MiiS Horus scope 5006 by Medimaging Integrated Solution, Inc (Miis)
- Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle by Boston Scientific
- GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 by Gimmi GmbH
- KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE by Karl Storz Endoscopy-America, Inc.
- DUAL-LUMEN CATHETER by Bistech, Inc.
- Ion Endoluminal System by Intuitive Surgical, Inc.
- Karl Storz Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) by Karl Storz SE & CO. KG
- B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM by Vision-Sciences, Inc.