Pentax
Perform cleaning, high-level disinfection, and/or sterilization according to the procedure specified in the Instructions for Use (Reprocessing) of this instrument.
21manufacturers in China registered for this device type
39catalogue numbers in this listing
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 | Hoya Corporation, Bulgaria |
|---|---|
| FDA product code | EOQ |
| Device type | Bronchoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K131028 |
| Record published | 2023-07-31 |
| Record revised | 2025-04-07 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant, Ethylene Oxide, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-09-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| OF-B181 | In distribution | ||
| OF-B80 | 10 | In distribution | |
| CS3010S | In distribution | ||
| OF-B179 | In distribution | ||
| CS-C3S | In distribution | ||
| OF-B155 | In distribution | ||
| OE-A52 | 20 | In distribution | |
| OE-A53 | In distribution | ||
| FB-15RBS | In distribution | ||
| EB-1575K | In distribution | ||
| BS-LL1 | In distribution | ||
| OF-B136 | In distribution | ||
| BS-B1 | In distribution | ||
| CS6002SN | In distribution | ||
| BS-LC1 | In distribution | ||
| CS6015ST | In distribution | ||
| FB-19TV | In distribution | ||
| OF-D1 | In distribution | ||
| OF-B75 | In distribution | ||
| EB-1975K | Withdrawn | ||
| OE-A52 | 20 | Withdrawn | |
| EB-1970TK | Withdrawn | ||
| FB-18V | Withdrawn | ||
| KS1011CS | Withdrawn | ||
| EB-1975K | Withdrawn | ||
| EB-1570K | Withdrawn | ||
| FB-15V | Withdrawn | ||
| OF-B17 | Withdrawn | ||
| EB-1970K | Withdrawn | ||
| FB-8V | Withdrawn | ||
| KW1811S | Withdrawn | ||
| EB-1990i | Withdrawn | ||
| KS1022CS | Withdrawn | ||
| EB-1970UK | Withdrawn | ||
| OF-B204 | Withdrawn | ||
| EB-1170K | Withdrawn | ||
| FB-18RBS | Withdrawn | ||
| KW2411S | Withdrawn | ||
| FB-10V | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope (Flexible Or Rigid) | Karl Storz GmbH & Co. KG | 248 |
| 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 |
| LoopView® | Macrolux Medical Technology Co., Ltd. | 15 |
Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Pentax of America, Inc. | 510(k) number | 2016-05-31 | Class II | Process control | The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cl | 113 units | 2019-08-19 |
| Pentax of America, Inc. | 510(k) number | 2016-05-31 | Class II | Packaging process control | Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS. | 1719 units | 2017-12-21 |
| Pentax of America, Inc. | 510(k) number | 2016-04-06 | Class II | Device Design | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s instrument channel. | 4,195 units | 2017-12-21 |
| Pentax of America, Inc. | 510(k) number | 2016-04-06 | Class II | Device Design | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope’s instrument channel. | 115 units | 2017-12-21 |
| Pentax of America, Inc. | 510(k) number | 2011-09-30 | Not classified | Employee error | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. | 18 units | 2012-11-27 |
| Pentax of America, Inc. | 510(k) number | 2011-01-11 | Class II | Device Design | This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011. | 1,349 – (Total – US) and 352 (Total – OUS) | 2018-03-13 |
| Pentax of America, Inc. | 510(k) number | 2011-01-11 | Class II | Device Design | This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011. | 1,349 – (Total – US) and 352 (Total – OUS) | 2018-03-13 |
| Pentax of America, Inc. | 510(k) number | 2011-01-11 | Class II | Device Design | This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011. | 1,349 – (Total – US) and 352 (Total – OUS) | 2018-03-13 |
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.