LigaSure
Tissue Fusion Open Instrument,Straight Jaw, Reusable
65manufacturers in China registered for this device type
44catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| 510(k) | K092879 |
| Record published | 2016-09-24 |
| Record revised | 2026-04-23 (version 14) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature -29 to 149 °F |
| Packaging | Case of 6, pack_or_inner_pack of 6, pack_or_inner_pack of 3, case of 12 |
| Sizes | Length 2.3 to 44 cm; outer diameter 5 to 20.6 mm; width 2.5 cm; outer diameter 25 cm; width 16.5 mm; length 15 ft |
| Distribution end date | 2026-06-16 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LF1212A | Length 19 cm | In distribution |
| LF3225C | Length 25 cm | In distribution |
| LF0500 | In distribution | |
| LF3225 | Width 2.5 cm | In distribution |
| LF1737 | Length 37 cm | In distribution |
| LF1923 | Length 23 cm | In distribution |
| LS1520 | Outer Diameter 5 mm | In distribution |
| LF3225 | Length 25 cm | In distribution |
| LigaSure 8 | In distribution | |
| LF1744 | Outer Diameter 5 mm | In distribution |
| LF1537 | Length 37 cm | In distribution |
| LF1823 | Length 23 cm | In distribution |
| LS1520 | Length 20 cm | In distribution |
| LS0300 | In distribution | |
| LS3110 | Length 2.8 cm | In distribution |
| LF5637 | Length 37 cm | In distribution |
| LF5644 | Length 44 cm | In distribution |
| LF1212A | Width 16.5 mm | In distribution |
| LF1944 | Outer Diameter 5 mm | In distribution |
| LF1937 | Outer Diameter 5 mm | In distribution |
| LS3092 | Length 2.5 cm | In distribution |
| LF3225C | 2.5 cm – 25 cm; | In distribution |
| LF1837 | Length 37 cm | In distribution |
| LF1930T | Length 30 cm | In distribution |
| LF1544 | Outer Diameter 5 mm | In distribution |
| LF1723 | Length 23 cm | In distribution |
| LF1212A | Length 19 cm | In distribution |
| LF1844 | Length 44 cm | In distribution |
| 150000088 | Length 15 ft | In distribution |
| LF2019 | Outer Diameter 20.6 mm | In distribution |
| LF1520 | Length 20 cm | Withdrawn |
| LS3090 | Length 2.5 cm | Withdrawn |
| LS2111 | Length 2.3 cm | Withdrawn |
| LF1637 | Length 37 cm | Withdrawn |
| LS3112 | Length 2.8 cm | Withdrawn |
| LS1500 | Outer Diameter 5 mm | Withdrawn |
| LS0010 | Withdrawn | |
| LS1500 | Length 37 cm | Withdrawn |
| LS2110 | Length 2.3 cm | Withdrawn |
| LS2070 | Length 2.5 cm | Withdrawn |
| LF1623 | Length 23 cm | Withdrawn |
| LF1644 | Outer Diameter 5 mm | Withdrawn |
| LS2071 | Length 2.5 cm | Withdrawn |
| LIGASUREZD | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091223 | 2009-09-11 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2021-12-06 | Class II | Device Design | Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or lo | 504 devices | 2023-05-11 |
| Covidien | 510(k) number | 2011-11-04 | Not classified | Nonconforming Material/Component | Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching. | 100,620 units | 2013-03-22 |
| Covidien | 510(k) number | 2011-11-04 | Not classified | Nonconforming Material/Component | Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching. | 20,190 units | 2013-03-22 |
| Covidien | 510(k) number | 2010-12-08 | Not classified | Device Design | During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue. | 25,009 units | 2012-03-27 |
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.