Vapr
VAPR TRIPOLAR 90 Degrees Suction Electrode 90 Degrees Suction with Integrated Handpiece and Hand Controls
65manufacturers in China registered for this device type
30catalogue numbers in this listing
1510(k) clearance
15recalls 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 | DePuy Mitek, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K974022 |
| Record published | 2015-09-01 |
| Record revised | 2026-03-26 (version 6) |
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 from 77 °F; Handling environment temperature from 25 °C; Handling environment temperature from 77 °F; Storage environment temperature from 25 °C |
| Distribution end date | 2024-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 225302 | In distribution | |
| 225314 | In distribution | |
| 228300 | In distribution | |
| 227202 | In distribution | |
| 225203 | In distribution | |
| 225202 | In distribution | |
| 227301 | In distribution | |
| 227355 | In distribution | |
| 227504 | In distribution | |
| 225305 | In distribution | |
| 227302 | In distribution | |
| 225213 | In distribution | |
| 227312 | In distribution | |
| 225304 | In distribution | |
| 225312 | In distribution | |
| 225303 | In distribution | |
| 228203 | In distribution | |
| 227305 | In distribution | |
| 227252 | In distribution | |
| 227213 | In distribution | |
| 227203 | In distribution | |
| 225301 | In distribution | |
| 228305 | In distribution | |
| 225028 | In distribution | |
| 225370 | In distribution | |
| 228370 | In distribution | |
| 228504 | In distribution | |
| 227211 | In distribution | |
| 225360 | Withdrawn | |
| 225361 | 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 |
|---|---|
| K143475 | 2015-04-03 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| DePuy Mitek, Inc. | 510(k) number | 2012-03-12 | Class II | Error in labeling | Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode | 376 units | 2015-06-05 |
| DePuy Mitek, Inc. | 510(k) number | 2010-06-07 | Not classified | Packaging process control | Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility | 112936 units | 2012-07-12 |
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 |
|---|---|---|---|---|---|
| 2015-11-23 | Class II | Process control | Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only | 127 | 2017-04-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility | 5176 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility | 4253 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility | 38096 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility | 36812 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility | 7576 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility | 4659 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility | 3408 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility | 21676 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility | 545,526 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility | 1414 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility | 28185 units | 2012-07-12 |
| 2010-06-07 | Not classified | Packaging process control | Product does not meet the packaging specifications for pouch seal integrity which could lead to a breach in sterility | 3940 units | 2012-07-12 |
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.