LAP Chole KIT 4 GK
Kit Contains: CA090, DIRECT DRIVE LCA 3/BX C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CTR12, 5x100 Kii OPT ZTHR DP 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX
46manufacturers in China registered for this device type
1catalogue number
26510(k) clearances naming this product code
35recalls 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 | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-09 |
| Record revised | 2021-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GK104-H | In distribution |
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 |
|---|---|
| K252442 | 2025-10-31 |
| K232880 | 2023-11-01 |
| K211043 | 2022-03-31 |
| K182024 | 2018-08-30 |
| K142427 | 2014-12-23 |
| K100959 | 2010-04-22 |
| K090275 | 2009-02-18 |
| K083638 | 2008-12-23 |
| K072674 | 2007-10-05 |
| K060629 | 2006-04-07 |
| K060534 | 2006-03-13 |
| K060096 | 2006-01-24 |
| K060051 | 2006-01-19 |
| K041795 | 2004-09-14 |
| K032889 | 2003-10-02 |
| K014047 | 2002-02-28 |
| K012884 | 2002-01-17 |
| K012968 | 2001-12-03 |
| K003871 | 2001-05-31 |
| K000545 | 2000-05-02 |
| K992852 | 1999-11-22 |
| K962395 | 1996-07-05 |
| K950702 | 1995-05-25 |
| K943489 | 1994-08-09 |
| K932995 | 1993-09-23 |
| K931895 | 1993-09-07 |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2025-12-11 | Class II | Nonconforming Material/Component | There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. | 450 units | |
| 2019-01-28 | Class II | Packaging | The product may not have met sterility requirements. Use of a non-sterile device on a patient may expose the patient to infectious agents. | 2,016 units | 2020-06-12 |
| 2017-05-04 | Class II | Under Investigation by firm | Due to possibility of insufficient sterilization. | 7,939 units total (870 units in US) | 2018-03-06 |
| 2013-10-21 | Class II | Package design/selection | Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The | 29,506 units | 2014-09-15 |
| 2011-06-17 | Not classified | Device Design | The recall was initiated because Applied Medical has confirmed specific lot numbers of the Direct Drive Grasper (model numbers C4130 and C4140) due to a potential weakness in the locking trigger, which could result in the trigger fracturing | 38,864 units total (24,868 units in US) | 2012-03-26 |
| 2011-06-17 | Not classified | Device Design | The recall was initiated because Applied Medical has confirmed specific lot numbers of the Direct Drive Grasper (model numbers C4130 and C4140) due to a potential weakness in the locking trigger, which could result in the trigger fracturing | 38,864 units total (24,868 units in US) | 2012-03-26 |
| 2011-06-17 | Not classified | Device Design | The recall was initiated because Applied Medical has confirmed specific lot numbers of the Direct Drive Grasper (model numbers C4130 and C4140) due to a potential weakness in the locking trigger, which could result in the trigger fracturing | 38,864 units total (24,868 units in US) | 2012-03-26 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2011-03-09 | |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2010-09-10 | Not classified | Process design | Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage. | 2,843 units for all products | 2011-03-09 |
| 2009-12-18 | Not classified | Component design/selection | The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii non-thre | 13,791 units total | 2011-09-06 |
| 2009-12-18 | Not classified | Component design/selection | The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii non-thre | 13,791 units total | 2011-09-06 |
| 2009-12-18 | Not classified | Component design/selection | The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii non-thre | 13,791 units total | 2011-09-06 |
| 2009-12-18 | Not classified | Component design/selection | The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426 and 1085506, of the 15 mm Kii non-thre | 13,791 units total | 2011-09-06 |
| 2009-06-04 | Not classified | Component design/selection | Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage. | 934 units | 2011-07-14 |
| 2008-06-25 | Not classified | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). | 14,113 total | 2012-03-26 |
| 2008-06-25 | Not classified | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). | 14,113 total | 2012-03-26 |
| 2008-06-25 | Not classified | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). | 14,113 total | 2012-03-26 |
| 2005-10-17 | Not classified | Process control | The Applied GelPort Laparoscopic Hand Access Device, Model C8004. product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit. | 117 Units | 2008-04-24 |
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.