Ion Tomosynthesis Board
Catalogue number 380456, listed by Intuitive Surgical, Inc., United States, under Bronchoscope (Flexible Or Rigid). 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
1catalogue number
11510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Hangzhou Broncus Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 1 |
| Tianjin Puli Ark Medical Technology Co., Ltd. | Dongli District | Tianjin | Contract manufacturer | 1 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
Showing 12 of 21. All 21 manufacturers in China registered for Bronchoscope (Flexible Or Rigid)
Record
| Listed by | Intuitive Surgical, Inc., United States |
|---|---|
| FDA product code | EOQ |
| Device type | Bronchoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2025-11-11 |
| Record revised | 2026-07-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 380456 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope (Flexible Or Rigid) | Karl Storz GmbH & Co. KG | 248 |
| Pentax | Hoya Corporation | 39 |
| Biopsy Forceps | Olympus Medical Systems Corp. | 31 |
| Single-Use flexible Video Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 27 |
| Pilling | Teleflex Medical LLC | 24 |
| Silicone cap | Efer Endoscopy | 22 |
| Bronchoscope (Flexible Or Rigid) | Intuitive Surgical, Inc. | 20 |
| Endoso | Hunan Endoso Life Technology Co., Ltd. | 20 |
| Exalt ™ | Boston Scientific Corporation | 17 |
| Grasping Forceps | Olympus Medical Systems Corp. | 16 |
| LungVision Tool | Body Vision Medical Ltd | 16 |
| Fujifilm | Fujifilm Corporation | 15 |
Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252045 | 2025-09-23 |
| K252528 | 2025-09-05 |
| K242070 | 2024-09-24 |
| K240135 | 2024-04-03 |
| K232984 | 2023-12-18 |
| K220299 | 2022-06-16 |
| K212048 | 2021-08-26 |
| K202370 | 2020-11-16 |
| K201146 | 2020-06-26 |
| K192367 | 2019-11-26 |
| K182188 | 2019-02-14 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-12-04 | Class II | Process control | Due to probe bags that may have a compromised or incomplete sterile pouch seal. | 110580 | |
| 2024-07-12 | Class II | Under Investigation by firm | There is a potential that the robotic system’s instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient’s airways. | 3 units | |
| 2021-08-06 | Class II | Under Investigation by firm | Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. | 1625 units | 2024-05-17 |
| 2020-10-23 | Class II | Device Design | The distal tip ring of the fully articulating catheter may become dislodged during the procedure. | 454 catheters | 2022-12-05 |
| 2020-06-10 | Class II | Device Design | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reproces | 67 units | |
| 2020-06-10 | Class II | Device Design | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reproces | 27 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.