Olympus
Pressure reducer with connector acc. to CGA No. 580, for Argon Plasma Coagulation
65manufacturers in China registered for this device type
283catalogue numbers in this listing
13510(k) clearances naming this product 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 | Olympus Winter & IBE Gmbh, 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, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140624 |
| Record published | 2016-09-21 |
| Record revised | 2024-07-25 (version 7) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2025-07-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| WA69300S | In distribution | ||
| WA69340S | In distribution | ||
| WA90300W | In distribution | ||
| WA94043A | In distribution | ||
| WA69416M | In distribution | ||
| WA99513A | 100 | In distribution | |
| WA94005A | 10 | In distribution | |
| WA69376M | In distribution | ||
| WA69400M | In distribution | ||
| WA22655C | 5 | In distribution | |
| A5378 | In distribution | ||
| WA99510A | In distribution | ||
| WA99514C | 15 | In distribution | |
| WA22507D | 12 | In distribution | |
| WA91311W | In distribution | ||
| WA99514A | 100 | In distribution | |
| WA22301S | 5 | In distribution | |
| WA69340M | In distribution | ||
| WA69310M | In distribution | ||
| A60000C | In distribution | ||
| WA69356S | In distribution | ||
| WA69312M | In distribution | ||
| WA69372S | In distribution | ||
| WA90004W | In distribution | ||
| WB50402W | In distribution | ||
| WB950243 | In distribution | ||
| WA69328S | In distribution | ||
| WA64200C | In distribution | ||
| WA60101C | In distribution | ||
| WA99516A | 100 | In distribution | |
| WA69320M | In distribution | ||
| WB91051W | In distribution | ||
| WA69334L | In distribution | ||
| WA90009A | In distribution | ||
| WA69312S | In distribution | ||
| WA69310S | In distribution | ||
| WA69422M | In distribution | ||
| A0223 | 10 | In distribution | |
| WA69374M | In distribution | ||
| WA69320S | In distribution | ||
| WA69346M | In distribution | ||
| WA22558C | 12 | In distribution | |
| WA69316L | In distribution | ||
| WA69384L | In distribution | ||
| WA00393S | 6 | In distribution | |
| WA69314M | In distribution | ||
| WA69330S | In distribution | ||
| WA69358S | In distribution | ||
| WA99512C | 15 | In distribution | |
| WA00013A | In distribution | ||
| WA91327U | In distribution | ||
| WA22606D | 5 | In distribution | |
| WA69334M | In distribution | ||
| WA60801C | In distribution | ||
| WA69336S | In distribution | ||
| WA69376L | In distribution | ||
| WA22540S | 5 | In distribution | |
| WB50403W | In distribution | ||
| WA91301W | In distribution | ||
| WA00387A | 10 | In distribution | |
| WA69338S | In distribution | ||
| WB990310 | 5 | In distribution | |
| WA91307W | In distribution | ||
| WA69342S | In distribution | ||
| WA90150W | In distribution | ||
| WA69350M | In distribution | ||
| WA69352L | In distribution | ||
| WA69414M | In distribution | ||
| WB990211 | 5 | In distribution | |
| WA69374S | In distribution | ||
| WA69322M | In distribution | ||
| WA22351C | 12 | In distribution | |
| WA69378M | In distribution | ||
| WA64321C | In distribution | ||
| WA69370S | In distribution | ||
| WA94001A | 10 | In distribution | |
| WA69314L | In distribution | ||
| WA99516C | 15 | In distribution | |
| WA69354M | In distribution | ||
| WA64310C | In distribution | ||
| WA69332L | In distribution | ||
| WA69384M | In distribution | ||
| WA69410M | In distribution | ||
| WA91327W | In distribution | ||
| WA69376S | In distribution | ||
| WA64850A | 6 | In distribution | |
| WA69330M | In distribution | ||
| WA69310L | In distribution | ||
| WA22621C | 5 | In distribution | |
| WA22503D | 12 | In distribution | |
| WA69316M | In distribution | ||
| WA69338L | In distribution | ||
| WA22302D | 12 | In distribution | |
| WA69384S | In distribution | ||
| WA69002M | In distribution | ||
| WA22306D | 12 | In distribution | |
| WA69358L | In distribution | ||
| WA91303W | In distribution | ||
| WA69314S | In distribution | ||
| WA69344M | In distribution | ||
| WA69330L | In distribution | ||
| WA69003M | In distribution | ||
| WA69418M | In distribution | ||
| WA69350S | In distribution | ||
| WA69370L | In distribution | ||
| WA69346S | In distribution | ||
| WA94007A | 10 | In distribution | |
| WA69320L | In distribution | ||
| WA69000L | In distribution | ||
| WA64050C | In distribution | ||
| WA91321W | In distribution | ||
| WA69372M | In distribution | ||
| WA22537D | 12 | In distribution | |
| WA69344S | In distribution | ||
| WA69390L | In distribution | ||
| WA69424M | In distribution | ||
| WA69334S | In distribution | ||
| WA22566S | 5 | In distribution | |
| WA69002L | In distribution | ||
| WB990210 | 5 | In distribution | |
| WA69352M | In distribution | ||
| WA69392M | In distribution | ||
| WA69356M | In distribution | ||
| WA69350L | In distribution | ||
| WA69342M | In distribution | ||
| WA69318S | In distribution | ||
| WA94002A | 10 | In distribution | |
| WA69390M | In distribution | ||
| A60003C | In distribution | ||
| WA90001A | In distribution | ||
| WA22557C | 12 | In distribution | |
| WA69382M | In distribution | ||
| WA69420M | In distribution | ||
| WA69001L | In distribution | ||
| WA69370M | In distribution | ||
| WA69318L | In distribution | ||
| WA69336L | In distribution | ||
| WA69300M | In distribution | ||
| WA69332M | In distribution | ||
| WA69338M | In distribution | ||
| WA22632D | 5 | In distribution | |
| WA69000M | In distribution | ||
| WA69372L | In distribution | ||
| WA64320C | In distribution | ||
| WA69352S | In distribution | ||
| WA69324M | In distribution | ||
| WA69332S | In distribution | ||
| WA22602D | 5 | In distribution | |
| WA69344L | In distribution | ||
| WA69374L | In distribution | ||
| WA69001M | In distribution | ||
| A60002C | In distribution | ||
| WA69318M | In distribution | ||
| WA94004A | 10 | In distribution | |
| WA91307C | In distribution | ||
| WA69356L | In distribution | ||
| WA69362M | In distribution | ||
| WA69340L | In distribution | ||
| WA94006A | 10 | In distribution | |
| WA22542S | 5 | In distribution | |
| WA69326S | In distribution | ||
| WA60800C | In distribution | ||
| WA69412M | In distribution | ||
| WA69300L | In distribution | ||
| WB990311 | 5 | In distribution | |
| A60001C | In distribution | ||
| WA99513C | 15 | In distribution | |
| WA69336M | In distribution | ||
| WA64120C | In distribution | ||
| WA69312L | In distribution | ||
| WA69380M | In distribution | ||
| WA94003A | 10 | In distribution | |
| WA69003L | In distribution | ||
| WA69392L | In distribution | ||
| WA69316S | In distribution | ||
| WA69346L | In distribution | ||
| WA69342L | In distribution | ||
| WA64051C | In distribution | ||
| WA90008A | In distribution | ||
| WA90002A | In distribution | ||
| WA63201C | Withdrawn | ||
| WA69212M | Withdrawn | ||
| WA69090M | Withdrawn | ||
| WA63051C | Withdrawn | ||
| WB990207 | 5 | Withdrawn | |
| WA69220M | Withdrawn | ||
| WA63211C | Withdrawn | ||
| WA64201C | Withdrawn | ||
| WA64210C | Withdrawn | ||
| A5379 | Withdrawn | ||
| WA63310C | Withdrawn | ||
| WA69054M | Withdrawn | ||
| WA63200C | Withdrawn | ||
| WA69216L | Withdrawn | ||
| WA69220L | Withdrawn | ||
| WA69058M | Withdrawn | ||
| WA69076L | Withdrawn | ||
| WA63320C | Withdrawn | ||
| WA69024L | Withdrawn | ||
| WA69076M | Withdrawn | ||
| WA69052L | Withdrawn | ||
| WA69070M | Withdrawn | ||
| WA69018M | Withdrawn | ||
| WA69038L | Withdrawn | ||
| WA69032M | Withdrawn | ||
| WA69042M | Withdrawn | ||
| WA69210L | Withdrawn | ||
| WB991007 | Withdrawn | ||
| WA69010L | Withdrawn | ||
| WA64211C | Withdrawn | ||
| WA69012M | Withdrawn | ||
| WA69082L | Withdrawn | ||
| WA69052M | Withdrawn | ||
| WA69216M | Withdrawn | ||
| WA69050M | Withdrawn | ||
| WA69030L | Withdrawn | ||
| WA69050L | Withdrawn | ||
| WA69020L | Withdrawn | ||
| WA22355A | Withdrawn | ||
| WA51193A | Withdrawn | ||
| WA69084M | Withdrawn | ||
| WA64311C | Withdrawn | ||
| WA69214L | Withdrawn | ||
| WA69092L | Withdrawn | ||
| WA69212L | Withdrawn | ||
| WA69046M | Withdrawn | ||
| WA69056M | Withdrawn | ||
| WA69210M | Withdrawn | ||
| WA69018L | Withdrawn | ||
| WA00014A | Withdrawn | ||
| WA69222M | Withdrawn | ||
| FSW991.067.003 | Withdrawn | ||
| WA69072L | Withdrawn | ||
| WA69218M | Withdrawn | ||
| WA69074M | Withdrawn | ||
| WA69016L | Withdrawn | ||
| WA69020M | Withdrawn | ||
| WA63121C | Withdrawn | ||
| WA69092M | Withdrawn | ||
| WA69034L | Withdrawn | ||
| WA51190A | Withdrawn | ||
| WA69030M | Withdrawn | ||
| WA69044L | Withdrawn | ||
| WA69056L | Withdrawn | ||
| WA69010M | Withdrawn | ||
| WA69080M | Withdrawn | ||
| WA69036M | Withdrawn | ||
| WA69074L | Withdrawn | ||
| WA69014M | Withdrawn | ||
| A0273 | Withdrawn |
Showing 250 of 283 catalogue numbers.
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 |
|---|---|
| K252043 | 2025-09-23 |
| K231777 | 2023-08-18 |
| K221522 | 2023-01-19 |
| K203682 | 2021-05-17 |
| K203277 | 2021-04-28 |
| K182587 | 2018-11-29 |
| K180200 | 2018-04-26 |
| K172535 | 2017-11-16 |
| K160053 | 2016-05-06 |
| K160639 | 2016-05-04 |
| K140624 | 2014-12-10 |
| K141225 | 2014-08-12 |
| K103032 | 2011-01-14 |
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2026-02-25 | Class II | Nonconforming Material/Component | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps’ jaw breaking during clinical use. | 444 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-07-25 | Class II | Component change control | Potential for the ESG-410 Electrosurgical Generator to display an error message: “E0662 System Error”, followed by either automatic single reboots of the device, or continuous reboot ‘loops’. | 155 units |
| Olympus Corporation of the Americas | 510(k) number | 2025-07-25 | Class II | Component change control | Potential for the ESG-410 Electrosurgical Generator to display an error message: “E0662 System Error”, followed by either automatic single reboots of the device, or continuous reboot ‘loops’. | 434 units |
| Olympus Corporation of the Americas | 510(k) number | 2024-09-04 | Class II | Software design | There was an increase in complaints indicating an occurrence of system error E1226 “Could not write to Audio Buffer” during procedures using the ESG-410 (SEP). | 279 units |
| Olympus Corporation of the Americas | 510(k) number | 2024-06-21 | Class II | Component design/selection | Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery | 86 |
| Olympus Corporation of the Americas | 510(k) number | 2023-12-15 | Class II | Under Investigation by firm | The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. | 11,123 units |
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.