Single Use Guide Sheath Kit
Olympus Single Use Guide Sheath Kit guides endotherapy accessories or ultrasound probes to a target within the tracheobronchial tree. It supports bronchoscopic collection of tissue,…
Olympus Single Use Guide Sheath Kit guides endotherapy accessories or ultrasound probes to a target within the tracheobronchial tree. It supports bronchoscopic collection of tissue, specimens or cells. The K-401 and K-402 configurations are intended for adult patients.
In these configurations, the guide sheath remains at the localized target and functions as an extended working channel for repeated sampling. The sheath has an insertion tube and an X-ray tip; biopsy forceps and position-marking stoppers are supplied with the kit.
K-401 and K-402 Configurations
K-401 includes a cytology brush, while K-402 omits it. Components and stoppers are sterile and individually packaged. These configurations use Olympus bronchoscopes with a working length of 600 mm or less and a channel of at least 2.0 mm, excluding ultrasonic bronchoscopes.
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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | EOQ |
| Device type | Bronchoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K212667 |
| Record published | 2018-09-21 |
| Record revised | 2024-04-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2022-06-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K-402 | In distribution | |
| K-401 | In distribution | |
| K-202 | Withdrawn | |
| K-204 | Withdrawn | |
| K-203 | Withdrawn | |
| K-201 | Withdrawn |
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 |
|---|---|
| K252341 | 2026-04-23 |
| K250862 | 2025-06-23 |
| K250118 | 2025-06-04 |
| K250957 | 2025-05-30 |
| K222861 | 2023-06-15 |
| K221631 | 2022-09-26 |
| K212667 | 2021-09-22 |
| K201300 | 2021-01-26 |
| K201758 | 2021-01-21 |
| K200342 | 2020-12-17 |
| K200397 | 2020-04-24 |
| K192164 | 2020-03-06 |
| K183419 | 2019-09-05 |
| K172726 | 2018-04-30 |
| K121959 | 2013-01-10 |
| K082720 | 2008-11-05 |
| K061313 | 2006-08-31 |
| K060243 | 2006-06-23 |
| K050220 | 2005-02-10 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2025-01-15 | Class I | Under Investigation by firm | Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient. | 454 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.