Cardiovascular Procedure Kit
181 catalogue numbers from 78233-01, listed by Terumo Cardiovascular Systems Corporation, United States, under Laparoscope, General & Plastic Surgery. 46 manufacturers in China are registered for this product code.
46manufacturers in China registered for this device type
181catalogue numbers in this listing
3510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (15), Jiangsu (13), Zhejiang (7). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Shenzhen Jingxintai Houseware Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Comhuge Medical Wire AND Harness Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Showing 12 of 46. All 46 manufacturers in China registered for Laparoscope, General & Plastic Surgery
Record
| Listed by | Terumo Cardiovascular Systems Corporation, United States |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083194 |
| Record published | 2024-04-10 |
| Record revised | 2026-07-01 (version 3) |
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 |
| Packaging | 2 piece case of 2, 5 piece case of 5, 10 piece case of 10, 4 piece case of 4, 6 piece case of 6, 20 piece case of 20 |
| Distribution end date | 2027-10-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 78233-01 | In distribution | |
| CX-NL159X | In distribution | |
| 76498 | In distribution | |
| 74454-05 | In distribution | |
| 78303 | In distribution | |
| 78235 | In distribution | |
| 78309 | In distribution | |
| 73442-02 | In distribution | |
| 73763-04 | In distribution | |
| 73782-03 | In distribution | |
| 75635-03 | In distribution | |
| 78298 | In distribution | |
| CX-FR470 | In distribution | |
| 78216 | In distribution | |
| 78078-01 | In distribution | |
| 76095-01 | In distribution | |
| CX-FR367 | In distribution | |
| 76646 | In distribution | |
| 76723-04 | In distribution | |
| 74861-02 | In distribution | |
| 75543-02 | In distribution | |
| 78079 | In distribution | |
| 74957-05 | In distribution | |
| CX-CZ206X | In distribution | |
| CX-CZ207X | In distribution | |
| 67017 | In distribution | |
| 78301 | In distribution | |
| CX-FR460 | In distribution | |
| 75706-02 | In distribution | |
| 73009-04 | In distribution | |
| 76781 | In distribution | |
| 78322 | In distribution | |
| 78363 | In distribution | |
| 78313 | In distribution | |
| 70893-09 | In distribution | |
| 76647 | In distribution | |
| CX-ZA093 | In distribution | |
| CX-IT611X | In distribution | |
| CX-FR416 | In distribution | |
| CX-IT610X | In distribution | |
| CX-FR465 | In distribution | |
| CX-ZA095X | In distribution | |
| 75498-02 | In distribution | |
| 76374-02 | In distribution | |
| 78335 | In distribution | |
| 71064-01 | In distribution | |
| 67020 | In distribution | |
| 78038 | In distribution | |
| 78165 | In distribution | |
| 75411-04 | In distribution | |
| CX-FR457 | In distribution | |
| CX-FR466 | In distribution | |
| 76317-01 | In distribution | |
| 78368 | In distribution | |
| 78044-01 | In distribution | |
| 77014-01 | In distribution | |
| 78166 | In distribution | |
| 78296 | In distribution | |
| 78385 | In distribution | |
| 77454-02 | In distribution | |
| 78395 | In distribution | |
| 78299 | In distribution | |
| CX-SK052X | In distribution | |
| 75643-03 | In distribution | |
| 76644-01 | In distribution | |
| 78326 | In distribution | |
| CX-CZ204 | In distribution | |
| 77113-01 | In distribution | |
| CX-FR469 | In distribution | |
| CX-FR461 | In distribution | |
| 77521-03 | In distribution | |
| CX-GE446 | In distribution | |
| CX-IT620 | In distribution | |
| 77272-01 | In distribution | |
| 78358 | In distribution | |
| 78168 | In distribution | |
| 65418-06 | In distribution | |
| CX-GE455 | In distribution | |
| 72386-02 | In distribution | |
| 76427-01 | In distribution | |
| 77742-01 | In distribution | |
| CX-BE135X | In distribution | |
| 77677-01 | In distribution | |
| 76776 | In distribution | |
| 78138-01 | In distribution | |
| 78315 | In distribution | |
| CX-IT621X | In distribution | |
| CX-FR415 | In distribution | |
| 70229-11 | In distribution | |
| 75485-04 | In distribution | |
| 78167 | In distribution | |
| 75607-01 | In distribution | |
| 75001-01 | In distribution | |
| 67021 | In distribution | |
| 78297 | In distribution | |
| 78306 | In distribution | |
| 78300 | In distribution | |
| 75290-02 | In distribution | |
| 78321 | In distribution | |
| 71175-06 | In distribution | |
| 78359 | In distribution | |
| 78367 | In distribution | |
| 78362 | In distribution | |
| 75600-02 | In distribution | |
| CX-FR456X | In distribution | |
| 65672-06 | In distribution | |
| 76513-02 | In distribution | |
| CX-IT606X | In distribution | |
| 72149-02 | In distribution | |
| CX-FR467 | In distribution | |
| 78200-01 | In distribution | |
| 78091 | In distribution | |
| 76777 | In distribution | |
| 78325 | In distribution | |
| 76202-02 | In distribution | |
| 73431-04 | In distribution | |
| 76491-02 | In distribution | |
| 71836-04 | In distribution | |
| 76643-01 | In distribution | |
| 78328 | In distribution | |
| 77765-01 | In distribution | |
| 74370-03 | In distribution | |
| 77655-02 | In distribution | |
| CX-IT619X | In distribution | |
| 73077 | In distribution | |
| 76822 | In distribution | |
| 78369 | In distribution | |
| CX-UK695 | In distribution | |
| CX-FR464 | In distribution | |
| 78010 | In distribution | |
| 78018-01 | In distribution | |
| 75563-02 | In distribution | |
| CX-NO028X | In distribution | |
| 66724 | In distribution | |
| CX-FR462 | In distribution | |
| 78294 | In distribution | |
| 76408-02 | In distribution | |
| 77638-01 | In distribution | |
| 76306-02 | In distribution | |
| CX-CZ205X | In distribution | |
| 70377-05 | In distribution | |
| 78365 | In distribution | |
| 77496-02 | In distribution | |
| 70700-04 | In distribution | |
| 78394 | In distribution | |
| 75581-04 | In distribution | |
| 76185-02 | In distribution | |
| 78304 | In distribution | |
| 77452-02 | In distribution | |
| CX-LI016 | In distribution | |
| 77369-02 | In distribution | |
| 75513-02 | In distribution | |
| 75030-03 | In distribution | |
| 67018 | In distribution | |
| 74203-02 | In distribution | |
| 78305 | In distribution | |
| 77757-01 | In distribution | |
| 78364 | In distribution | |
| CX-FR468 | In distribution | |
| 73789-02 | In distribution | |
| 76273-02 | Withdrawn | |
| 75959-02 | Withdrawn | |
| 78091-01 | Withdrawn | |
| 78342 | Withdrawn | |
| 77746-01 | Withdrawn | |
| 76775-01 | Withdrawn | |
| 70893-07 | Withdrawn | |
| 76921-01 | Withdrawn | |
| 76738-01 | Withdrawn | |
| 74101-01 | Withdrawn | |
| 70985-05 | Withdrawn | |
| 74737-02 | Withdrawn | |
| 75197-01 | Withdrawn | |
| 75880-01 | Withdrawn | |
| 78122-01 | Withdrawn | |
| 76839-02 | Withdrawn | |
| 73346-02 | Withdrawn | |
| 74121-03 | Withdrawn | |
| 74672-02 | Withdrawn | |
| 76873-03 | Withdrawn | |
| 74965-05 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 3,796 |
| Surgical Direct | Surgical Direct, Inc. | 2,319 |
| Novo Surgical | Novo Surgical, Inc. | 1,320 |
| Elmed Incorporated | Elmed, Inc. | 911 |
| Laparoscope, General & Plastic Surgery | Karl Storz GmbH & Co. KG | 774 |
| Snowden-Pencer | Steris Corporation | 693 |
| Millennium | Avalign Technologies, Inc. | 683 |
| Hermann Medizintechnik GmbH | Hermann Medizintechnik Gmbh | 615 |
| Clickline | Karl Storz GmbH & Co. KG | 582 |
| V. Mueller | Carefusion 2200, Inc. | 553 |
| Grasping forceps | Sopro-Comeg GmbH | 462 |
| Gimmi | Gimmi Gmbh | 387 |
Showing 12 of 1,584. All products under Laparoscope, General & Plastic Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092789 | 2010-05-12 |
| K083194 | 2009-01-16 |
| K031891 | 2003-07-29 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Terumo Cardiovascular Systems Corporation | 510(k) number | 2011-01-10 | Not classified | Other | The Bipolar cord product specification indicates the product has a service life of 50 uses. However the IFU does not specify an end of service life. The firm has recieved 46 complaints on the Bipolar cord. The firm investigated and found | 2782 cords | 2011-07-13 |
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 |
|---|---|---|---|---|---|
| 2013-12-12 | Class II | Process control | Sterility of medical devices intended for use in surgical procedures may be compromised. | 26 units | 2015-07-28 |
| 2011-06-10 | Not classified | Device Design | Terumo Cardiovascular Systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the VirtuoSaph Plus Endoscopic Vessel Harvesting System during cases in a limited production launch situat | 35 units | 2011-07-27 |
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.