Core E3™
Suction/Irrigator, 5mm x 32cm Probe
46manufacturers in China registered for this device type
2catalogue numbers in this listing
8510(k) clearances naming this product code
40recalls 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 | ConMed Corporation, United States |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2021-11-05 |
| Record revised | 2024-04-18 (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 |
| Storage | Storage environment temperature 15 to 25 °C; Storage environment temperature 59 to 77 °F; Storage environment humidity 30 to 65 % RH; Special storage condition: KEEP DRY; KEEP OUT OF SUNLIGHT |
| Packaging | Box |
| Distribution end date | 2024-04-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CD8300-B | 5 | Withdrawn | |
| CD8185-B | 5 | 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 |
|---|---|
| K202303 | 2021-02-19 |
| K201593 | 2020-07-08 |
| K183600 | 2019-03-13 |
| K173822 | 2018-09-11 |
| K172940 | 2017-10-18 |
| K161017 | 2016-05-09 |
| K142464 | 2015-03-05 |
| K073009 | 2007-12-07 |
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 |
|---|---|---|---|---|---|
| 2019-03-21 | Class II | Process control | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | 2931 | 2023-01-17 |
| 2019-03-21 | Class II | Process control | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | 11835 | 2023-01-17 |
| 2019-03-21 | Class II | Process control | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | 69385 | 2023-01-17 |
| 2019-03-21 | Class II | Process control | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | 5034 | 2023-01-17 |
| 2019-03-21 | Class II | Process control | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | 1310 | 2023-01-17 |
| 2019-03-21 | Class II | Process control | Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product | 7930 | 2023-01-17 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 518,622 instruments | 2012-08-30 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 19,334 instruments | 2012-08-30 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 679,424 instruments | 2012-08-30 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 53,691 instruments | 2012-08-30 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 144,865 instruments | 2012-08-30 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 609,631 instruments | 2012-08-30 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 34,738 instruments | 2012-08-30 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 271,768 instruments | 2012-08-30 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 11,390 instruments | 2012-08-30 |
| 2007-09-12 | Not classified | Packaging process control | Sterility (package integrity) compromised — Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. | 6,969 instruments | 2012-08-30 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 32,008 units | 2012-07-31 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 122,214 units | 2012-07-31 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 711,245 units | 2012-07-31 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 1,725,957 units | 2012-07-31 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 357,017 units | 2012-07-31 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 15,549 units | 2012-07-31 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 2,232,896 units | 2012-07-31 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 2,066,661units | 2012-07-31 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 89,366 units | 2012-07-31 |
| 2006-11-10 | Not classified | Packaging process control | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 48,566 units | 2012-07-31 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 60 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 65 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 27 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 2 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 6 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 10 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 14 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 1 unit | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 13 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 47 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When the grasper jaws had broken they had done so at the junction of the jaw and the tube. In no instances was it reported to the company | 38 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 6 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 17 units | 2012-08-30 |
| 2006-10-12 | Not classified | Nonconforming Material/Component | The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | 556 units | 2012-08-30 |
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.