Detachaport
Detachaport Obturator AND Seal SET With Reducers, (1) 12MM X 100MM Obturator, (2) 10/12MM Seal Sets
46manufacturers in China registered for this device type
30catalogue 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 |
| 510(k) | K952977 |
| Record published | 2016-09-24 |
| Record revised | 2024-07-25 (version 5) |
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 |
| Storage | Storage environment temperature 10 to 32 °C; Storage environment temperature 50 to 90 °F |
| Packaging | Box of 10, case of 10, pouch of 10 |
| Sizes | Length 70 to 150 mm; outer diameter 5 to 12 mm |
| Distribution end date | 2022-11-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1-7045 | 5 Millimeter | 10 | In distribution |
| 1-7017 | 5 Millimeter Seal Set | 10 | Withdrawn |
| 1-7013 | 5 Millimeter | 10 | Withdrawn |
| 1-7012 | 150 Millimeter | Withdrawn | |
| 1-7006 | Length 150 mm | Withdrawn | |
| 1-7024 | Length 100 mm | 10 | Withdrawn |
| 1-7055 | Length 100 mm | Withdrawn | |
| 1-7042 | Withdrawn | ||
| 1-7018 | Outer Diameter 5 mm | 10 | Withdrawn |
| 1-7011 | 100 Millimeter | Withdrawn | |
| 1-7057 | Open Entry Wedge | Withdrawn | |
| 1-7056 | Length 150 mm | Withdrawn | |
| 1-7009 | Outer Diameter 10 mm | Withdrawn | |
| 1-7016 | 70 Millimeter Obturator | 10 | Withdrawn |
| 1-7025 | 10 Millimeter Seal Set | 10 | Withdrawn |
| 1-7008 | Length 100 mm | Withdrawn | |
| 1-7052 | 10 | Withdrawn | |
| 1-7007 | Outer Diameter 5 mm | Withdrawn | |
| 1-7026 | Outer Diameter 12 mm | 10 | Withdrawn |
| 1-7020 | Outer Diameter 10 mm | 10 | Withdrawn |
| 1-7030 | Length 100 mm | 10 | Withdrawn |
| 1-7001 | Outer Diameter 5 mm | Withdrawn | |
| 1-7003 | Outer Diameter 10 mm | Withdrawn | |
| 1-7019 | 5 Millimeter Seal Set | 10 | Withdrawn |
| 1-7005 | Outer Diameter 12 mm | Withdrawn | |
| 1-7033 | Length 100 mm | 10 | Withdrawn |
| 1-7021 | Seal Set | 10 | Withdrawn |
| 1-7002 | Length 100 mm | Withdrawn | |
| 1-7044 | 12 Millimeter | 10 | Withdrawn |
| 1-7040 | 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.