Lapra-TY
Lapra-TY Suture Clip Applier 33cm Shaft Length -11mm Diameter
9manufacturers in China registered for this device type
1catalogue number
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Tianjin Huahong Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 6 |
| Sinolinks Medical Innovation, Inc. | Changzhou | Jiangsu | Complaint-file establishment | 5 |
| Fengh Medical Co., Ltd. | Jiangyin | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Ethicon Endo-Surgery, Inc., United States |
|---|---|
| FDA product code | GDO |
| Device type | Applier, Surgical, Clip |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-15 |
| Record revised | 2023-07-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Case of 3, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KA200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Weck | Teleflex Medical LLC | 996 |
| Teleflex | Teleflex Medical LLC | 61 |
| Aesculap | Aesculap AG | 46 |
| Ligaclip | Ethicon Endo-Surgery, Inc. | 29 |
| Surgical Direct | Surgical Direct, Inc. | 28 |
| Elmed | Elmed, Inc. | 23 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 19 |
| Ambler Surgical | Ambler Surgical, LLC | 19 |
| Europclip | Ackermann Instrumente Gmbh | 17 |
| Lazic | Peter Lazic Gmbh | 15 |
| Artisential Clip Applier Large | LivsMed Inc. | 14 |
| Artisential Clip Applier Medium Large | LivsMed Inc. | 14 |
Showing 12 of 73. All products under Applier, Surgical, Clip
Recalls
3 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 |
|---|---|---|---|---|---|
| 2013-04-12 | Class II | Under Investigation by firm | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/ | 738,356 | 2014-05-01 |
| 2013-04-12 | Class II | Under Investigation by firm | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/ | 49,357 | 2014-05-01 |
| 2013-04-12 | Class II | Under Investigation by firm | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/ | 10,488 | 2014-05-01 |
| 2004-06-07 | Not classified | Other | This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures. | 120,4015 | 2008-10-29 |
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.