Caiman
Caiman Vessel Sealing Instrument, (440 mm), diam. 5 mm, (26,50 mm), sterile, disposable, package of 6 pieces
65manufacturers in China registered for this device type
5catalogue numbers in this listing
18510(k) clearances naming this product code
6recalls on this code
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 | Aesculap AG, Germany |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-10-10 |
| Record revised | 2021-05-07 (version 9) |
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 |
| Distribution end date | 2021-10-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PL731SU | Working length (mm) : 440.000 MM | 3 | In distribution |
| PL730SU | Working length (mm) : 240.000 MM | 3 | In distribution |
| PL722SU | Diameter (mm) : 5.000 MM | 6 | Withdrawn |
| PL718SU | Working length (mm) : 240.000 MM | 6 | Withdrawn |
| PL720SU | Working length (mm) : 360.000 MM | 6 | 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 |
|---|---|
| K203461 | 2020-12-18 |
| K202938 | 2020-10-30 |
| K183180 | 2019-03-12 |
| K151858 | 2015-07-21 |
| K151696 | 2015-07-20 |
| K140839 | 2014-04-28 |
| K130596 | 2013-03-22 |
| K110695 | 2011-06-28 |
| K014207 | 2002-03-21 |
| K014172 | 2002-03-19 |
| K012986 | 2001-10-03 |
| K001330 | 2000-05-30 |
| K971310 | 1997-07-18 |
| K970541 | 1997-03-28 |
| K953446 | 1995-09-29 |
| K952524 | 1995-06-29 |
| K940936 | 1994-04-19 |
| K922576 | 1993-06-10 |
Recalls
6 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 |
|---|---|---|---|---|---|
| 2023-03-21 | Class II | Device Design | Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient’s body. | 6 pieces | |
| 2019-08-07 | Class II | Unknown/Undetermined by firm | possibility of the sterility batch being insufficiently sterilized | 3 unit of Lot 837B | 2020-05-12 |
| 2019-08-07 | Class II | Unknown/Undetermined by firm | possibility of the sterility batch being insufficiently sterilized | 0 | 2020-05-12 |
| 2017-01-09 | Class II | Nonconforming Material/Component | Generators may have a faulty component which could impact the proper functioning of the device. | 24 generators | 2017-06-14 |
| 2013-09-10 | Class II | Device Design | Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control. | 85 | 2014-10-20 |
| 2013-01-18 | Class II | Nonconforming Material/Component | The bipolar energy did not stop after release of the foot pedal. | 59 | 2014-01-08 |
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.