Ablaor / Eflex
Vulcan Eflex Ablator Ablator Probe With Integrated Cable
21manufacturers in China registered for this device type
1catalogue number
19510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HRX |
| Device type | Arthroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 888.1100 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K003893 |
| Record published | 2015-08-29 |
| Record revised | 2024-10-28 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72200683 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 299 |
| Arthroscope | Karl Storz GmbH & Co. KG | 278 |
| Conmed/Linvatec | Provision | 265 |
| Arthroscope | Smith & Nephew, Inc. | 255 |
| Medline | Medline Industries, Inc. | 205 |
| Arthroscope | Sterilmed, Inc. | 184 |
| Sustainable Technologies | Provision | 150 |
| Medline Renewal | Medline Industries, Inc. | 123 |
| Stryker | Provision | 113 |
| Arthrex® | Arthrex, Inc. | 109 |
| Arthrex | Provision | 109 |
| Eberle | Eberle GmbH & Co. KG | 92 |
Showing 12 of 567. All products under Arthroscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201349 | 2020-07-20 |
| K192155 | 2019-09-04 |
| K171794 | 2017-06-27 |
| K072675 | 2007-10-15 |
| K062849 | 2007-01-19 |
| K051326 | 2005-06-15 |
| K043395 | 2005-01-12 |
| K031605 | 2003-06-18 |
| K030196 | 2003-02-20 |
| K003572 | 2001-02-15 |
| K001226 | 2000-06-26 |
| K981156 | 1998-05-20 |
| K970511 | 1997-08-12 |
| K971676 | 1997-06-27 |
| K971253 | 1997-06-13 |
| K941036 | 1994-09-28 |
| K940222 | 1994-06-29 |
| K922519 | 1994-03-29 |
| K901617 | 1990-05-29 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2020-06-24 | Class II | Process design | The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve | 137 Lot 2042492; 130 Lot 2049408 | |
| 2009-05-27 | Not classified | Package design/selection | The sterility of the device cannot be assured | 67,697 units | 2012-05-08 |
| 2009-05-27 | Not classified | Package design/selection | The sterility of the device cannot be assured | 67,697 units | 2012-05-08 |
| 2008-08-07 | Not classified | Packaging process control | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. | 3,504 units | 2012-05-08 |
| 2008-08-07 | Not classified | Packaging process control | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. | 4,044 units | 2012-05-08 |
| 2008-08-07 | Not classified | Packaging process control | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. | 11,469 units | 2012-05-08 |
| 2008-08-07 | Not classified | Packaging process control | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. | 3,222 units | 2012-05-08 |
| 2002-11-08 | Not classified | Process control | Potential for non sterility as package tray does not contain aeration holes for ETO processing. | 77 units | 2005-04-20 |
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.