VenaCure Evlt
VenaCure 25cm Procedure Kit w/ Spotlight OPS Sheath, 1 Fiber w/ SMA Connector
92manufacturers in China registered for this device type
30catalogue numbers in this listing
16510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Beijing (28), Guangdong (21), Hebei (13). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Changsha Gomecy Electronics Co., Ltd. | Changsha | Hunan | Contract manufacturer | 9 |
| Gymmax Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Guangzhou Niansheng Beauty Equipment Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
| Beijing Syntech Laser Co., Ltd. | Beijing | Beijing | Contract manufacturer | 5 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Wuhan Dimed Laser Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 3 |
| Chengdu Vantron Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Shanghai Shengguang Science & Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
Showing 12 of 92. All 92 manufacturers in China registered for Powered Laser Surgical Instrument
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K102796 |
| Record published | 2016-09-20 |
| Record revised | 2024-03-25 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 27 °C |
| Packaging | Box of 5 |
| Sizes | Length 25 to 2500 cm; needle gauge 19 to 21 G; outer diameter 1.2 to 1.5 mm; catheter gauge 4 Fr |
| Distribution end date | 2021-09-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 51403008 | Outer Diameter 1.3 mm | In distribution |
| 11403002 | Length 65 cm | In distribution |
| 11403006 | Needle Gauge 19 G | In distribution |
| 51403007 | Catheter Gauge 4 Fr | In distribution |
| EVLT/25-OPS | Needle Gauge 19 G | In distribution |
| 11403302 | Catheter Gauge 4 Fr | In distribution |
| 51403009 | Outer Diameter 1.3 mm | In distribution |
| EVLT/55-OPS | Needle Gauge 19 G | In distribution |
| 51403002 | Length 65 cm | In distribution |
| 11403003 | Needle Gauge 21 G | In distribution |
| 11403301 | Catheter Gauge 4 Fr | In distribution |
| EVLT55OPSFO | Length 2500 cm | In distribution |
| 11403005 | Length 45 cm | In distribution |
| EVLTPVAKUS | Outer Diameter 1.5 mm | In distribution |
| EVLT/80-OPS | Catheter Gauge 4 Fr | In distribution |
| 11403004 | Length 90 cm | In distribution |
| 51403005 | Needle Gauge 21 G | In distribution |
| EVLT/PVAK | Outer Diameter 1.5 mm | In distribution |
| 51403001 | Needle Gauge 21 G | In distribution |
| 51403010 | Length 65 cm | In distribution |
| 11403012 | Needle Gauge 21 G | In distribution |
| 11403013 | Length 65 cm | In distribution |
| 11403007 | Needle Gauge 19 G | In distribution |
| 11403001 | Length 45 cm | In distribution |
| 51402008 | Needle Gauge 21 G | Withdrawn |
| 11402002 | Length 65 cm | Withdrawn |
| 11402001 | Length 45 cm | Withdrawn |
| 51402007 | Length 45 cm | Withdrawn |
| 51402005 | Length 45 cm | Withdrawn |
| 51402006 | Catheter Gauge 4 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accu-Beam | Transamerican Technologies International | 181 |
| Powered Laser Surgical Instrument | Weinert Fiber Optics Inc. | 117 |
| Waterlase Laser Tips | Biolase Technology, Inc. | 112 |
| ProFlex™ | Innovaquartz LLC | 109 |
| Dornier MedTech | Dornier Medtech America, Inc. | 91 |
| Powered Laser Surgical Instrument | Ophthalmed LLC | 90 |
| Optilite | Convergent Laser Technologies | 87 |
| Reusable Surgical Optical Fiber | Quanta System Spa | 78 |
| Single use Surgical Optical Fiber | Quanta System Spa | 70 |
| Powered Laser Surgical Instrument | Lutronic Corporation | 57 |
| Waterlase iPlus Dental Laser System | Biolase Technology, Inc. | 53 |
| Leoni™ | Weinert Fiber Optics Inc. | 49 |
Showing 12 of 2,654. All products under Powered Laser Surgical Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231945 | 2023-07-20 |
| K181044 | 2018-07-05 |
| K171921 | 2017-08-24 |
| K162914 | 2016-11-16 |
| K142614 | 2014-10-10 |
| K133561 | 2013-12-19 |
| K130671 | 2013-03-26 |
| K112600 | 2012-01-30 |
| K110225 | 2011-05-13 |
| K102796 | 2010-12-15 |
| K100199 | 2010-11-26 |
| K073464 | 2008-01-23 |
| K071959 | 2007-08-01 |
| K070378 | 2007-03-09 |
| K061178 | 2006-06-12 |
| K031233 | 2003-06-18 |
Recalls Naming This Product
18 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 |
|---|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2022-08-10 | Class II | Under Investigation by firm | OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged s | 40 units | |
| AngioDynamics, Inc. | 510(k) number | 2019-06-27 | Class II | Under Investigation by firm | The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from be | 109 | 2020-07-29 |
| AngioDynamics, Inc. | 510(k) number | 2013-04-30 | Class II | Labeling mix-ups | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size. | Domestic Only: 1) 300 units, 2) 300 units, 3) 151 units. | 2016-11-09 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 158 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 1297 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 3165 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 4252 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 540 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 127 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 39 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 664 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 531 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 858 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 48 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 225 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 10 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 186 units | 2016-02-01 |
| Angiodynamics Worldwide Headquarters | 510(k) number | 2011-11-10 | Not classified | Process control | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid p | 105 units | 2016-02-01 |
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.