Endopath Xcel
Endopath XCEL Dilating Tip Trocar Paks containing: 1 Dilating Tip trocar with Stability Sleeve and 1 Stability Sleeve for Dilating Tip Trocar
46manufacturers in China registered for this device type
29catalogue numbers in this listing
31510(k) clearances naming this product code
29recalls 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 | Ethicon Endo-Surgery, Inc., United States |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-07-15 |
| Record revised | 2026-04-07 (version 7) |
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 | Special storage condition: Keep Dry; Special storage condition: Store in a cool, Dry place |
| Packaging | Box of 6, case of 24, case of 36, case of 54 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B11LPH | In distribution | |
| D11LT | In distribution | |
| D5LT | In distribution | |
| B12LT | In distribution | |
| B5XT | In distribution | |
| K11LT | In distribution | |
| K5LT | In distribution | |
| B12LPH | In distribution | |
| K5ST | In distribution | |
| B5ST | In distribution | |
| CB5ST | In distribution | |
| B5LT | In distribution | |
| D5ST | In distribution | |
| B12XT | In distribution | |
| CB11LT | In distribution | |
| B11LP | In distribution | |
| D12LT | In distribution | |
| B8LT | In distribution | |
| B15LT | In distribution | |
| K12LT | In distribution | |
| B12LP | In distribution | |
| D12XT | In distribution | |
| CB12LT | In distribution | |
| B12SRT | In distribution | |
| B12LTH | In distribution | |
| B11LT | In distribution | |
| B11LTH | In distribution | |
| CB5LT | In distribution | |
| H12LP | 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 |
|---|---|
| K122511 | 2012-10-01 |
| K070198 | 2007-06-13 |
| K062209 | 2006-10-10 |
| K032676 | 2003-10-30 |
| K020428 | 2002-03-04 |
| K013576 | 2002-01-25 |
| K011538 | 2001-08-09 |
| K011501 | 2001-07-19 |
| K011257 | 2001-07-13 |
| K010870 | 2001-06-18 |
| K992612 | 1999-10-14 |
| K990028 | 1999-04-01 |
| K980023 | 1998-03-18 |
| K980022 | 1998-03-09 |
| K973139 | 1997-11-13 |
| K972578 | 1997-10-01 |
| K972679 | 1997-09-19 |
| K971475 | 1997-08-21 |
| K971738 | 1997-08-07 |
| K963760 | 1997-01-08 |
| K954089 | 1995-11-02 |
| K952842 | 1995-07-31 |
| K951546 | 1995-06-21 |
| K951444 | 1995-04-25 |
| K946241 | 1995-01-27 |
| K941027 | 1994-08-23 |
| K933160 | 1993-10-01 |
| K924916 | 1993-06-25 |
| K932282 | 1993-06-22 |
| K931111 | 1993-06-22 |
| K924035 | 1993-04-07 |
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 |
|---|---|---|---|---|---|
| 2018-03-26 | Class II | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator o | 14873 | 2020-04-08 |
| 2018-03-26 | Class II | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator o | 118352 | 2020-04-08 |
| 2018-03-26 | Class II | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator o | 11074 | 2020-04-08 |
| 2018-03-26 | Class II | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator o | 1500 | 2020-04-08 |
| 2018-03-26 | Class II | Process control | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator o | 95233 | 2020-04-08 |
| 2013-04-08 | Class II | Packaging | The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device. | 327,648 instruments | 2013-12-24 |
| 2008-12-09 | Not classified | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy | 21 lots, 5,952 pieces | 2010-10-20 |
| 2008-12-09 | Not classified | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy | 19 lots, 7,104 pieces | 2010-10-20 |
| 2008-12-09 | Not classified | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy | 13 lots, 2,304 pieces | 2010-10-20 |
| 2008-12-09 | Not classified | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy | 48 (labeled as LLC) lots + 4 (labeled as Inc.) lots, totalin | 2010-10-20 |
| 2008-12-09 | Not classified | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy | 32 lots, 18,528 pieces | 2010-10-20 |
| 2008-12-09 | Not classified | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy | 4 lots, 552 pieces | 2010-10-20 |
| 2008-12-09 | Not classified | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy | 30 lots, 11,352 pieces | 2010-10-20 |
| 2008-12-09 | Not classified | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy | 13 lots, 2,448 pieces | 2010-10-20 |
| 2008-12-09 | Not classified | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy | 40 lots totalling 27,480 pieces | 2010-10-20 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 48cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 48 cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 186 cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 15 cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 24 cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may compromised the sterility of the device. | 414 cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 24 cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 76 cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 120 cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 168 cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 288cases/6 devices per case. | 2012-09-26 |
| 2006-04-20 | Not classified | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. | 120 cases/6 devices per case. | 2012-09-26 |
| 2003-11-25 | Not classified | Nonconforming Material/Component | A defective articulation band may result in improper staple formation with possible hematosis. | 36 | 2012-05-09 |
| 2003-11-25 | Not classified | Nonconforming Material/Component | A defective articulation band may result in improper staple formation with possible hematosis. | 72 | 2012-05-09 |
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.