Taut
Weckvista Access Balloon Port 12 Millimeter X 100 Millimeter
46manufacturers in China registered for this device type
53catalogue numbers in this listing
1510(k) clearance
24recalls 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K010007 |
| Record published | 2019-04-16 |
| Record revised | 2025-09-24 (version 10) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 6, box of 4, case of 4, pack of 6, pack of 4, case of 6 |
| Sizes | Length 53 to 125 mm; width 5 to 15 mm; length 7.74 to 9.67 in; length 100 cm |
| Distribution end date | 2021-07-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN914242 | Width 5 mm | In distribution |
| IPN007724 | Width 15 mm | In distribution |
| IPN006611 | Length 125 mm | In distribution |
| IPN028436 | In distribution | |
| IPN006696 | Length 7.74 in | In distribution |
| IPN006599 | Length 125 mm | In distribution |
| IPN006603 | Width 10 mm | In distribution |
| IPN914257 | Width 5 mm | In distribution |
| IPN914256 | Width 5 mm | In distribution |
| IPN028437 | In distribution | |
| IPN006606 | Length 100 mm | In distribution |
| IPN914249 | Length 70 mm | In distribution |
| IPN006690 | Length 100 mm | In distribution |
| IPN006636 | Width 10 mm | In distribution |
| IPN006638 | Length 100 mm | In distribution |
| IPN006943 | Length 70 mm | In distribution |
| IPN006605 | Width 10 mm | In distribution |
| IPN006592 | Length 70 mm | In distribution |
| IPN914267 | Width 8 mm | In distribution |
| IPN006595 | Length 100 mm | In distribution |
| IPN914270 | Width 12 mm | In distribution |
| IPN006609 | Width 12 mm | In distribution |
| IPN006597 | Width 5 mm | In distribution |
| IPN006598 | Width 5 mm | In distribution |
| IPN006614 | Width 12 mm | In distribution |
| IPN006694 | Length 110 mm | In distribution |
| IPN914265 | Length 100 mm | In distribution |
| IPN006607 | Width 10 mm | In distribution |
| IPN914253 | Length 125 mm | In distribution |
| IPN006593 | Width 5 mm | In distribution |
| IPN006590 | Width 5 mm | In distribution |
| IPN914248 | Length 70 mm | In distribution |
| IPN914245 | Width 10 mm | In distribution |
| IPN006942 | Length 70 mm | In distribution |
| IPN006600 | Width 5 mm | In distribution |
| IPN006621 | Length 100 mm | In distribution |
| IPN006596 | Length 100 mm | In distribution |
| IPN914264 | Length 100 mm | In distribution |
| IPN006613 | Width 12 mm | In distribution |
| IPN006691 | Length 100 mm | In distribution |
| IPN006591 | Length 70 mm | In distribution |
| IPN006608 | Length 100 mm | In distribution |
| IPN006601 | Length 100 mm | In distribution |
| IPN006616 | Length 125 mm | In distribution |
| IPN006610 | Length 125 mm | In distribution |
| IPN006612 | Width 12 mm | In distribution |
| IPN006635 | Length 70 mm | In distribution |
| IPN006698 | Length 9.67 in | In distribution |
| IPN006637 | Width 10 mm | In distribution |
| IPN927772 | Width 5 mm | In distribution |
| IPN006689 | Width 12 mm | In distribution |
| IPN006615 | Length 100 mm | In distribution |
| IPN006693 | Width 15 mm | 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 |
|---|---|
| K082156 | 2008-09-10 |
Recalls Naming This Product
12 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints of leakage of insufflation gas through the device. | 55,521 total | 2016-01-28 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints of leakage of insufflation gas through the device. | 55,521 total | 2016-01-28 |
| Teleflex Medical LLC | 510(k) number | 2014-03-11 | Class II | Nonconforming Material/Component | Complaints of leakage of insufflation gas through the device. | 55,521 total | 2016-01-28 |
Recalls
11 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 |
|---|---|---|---|---|---|
| 2016-09-09 | Class II | Process control | The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers. | 160 ea. in total | 2017-08-25 |
| 2016-09-09 | Class II | Process control | The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers. | 160 ea. in total | 2017-08-25 |
| 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| 2014-03-11 | Class II | Nonconforming Material/Component | Complaints of leakage of insufflation gas through the device. | 55,521 total | 2016-01-28 |
| 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| 2014-03-11 | Class II | Nonconforming Material/Component | Complaints of leakage of insufflation gas through the device. | 55,521 total | 2016-01-28 |
| 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| 2014-03-11 | Class II | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. | 55,521 ea. in total | 2017-08-15 |
| 2014-03-11 | Class II | Nonconforming Material/Component | Complaints of leakage of insufflation gas through the device. | 55,521 total | 2016-01-28 |
| 2010-05-12 | Not classified | Other | Balloon does not hold air or water once inflated. | 366 eaches | 2010-10-27 |
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.