Versaport
Bladeless Low Profile Trocar with Fixation Cannula
46manufacturers in China registered for this device type
53catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K112349 |
| Record published | 2016-09-24 |
| Record revised | 2025-06-24 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 130 °F |
| Packaging | Case of 6, case of 3 |
| Sizes | Outer diameter 2 to 12 mm |
| Distribution end date | 2026-06-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ONB5SHF | Outer Diameter 5 mm | In distribution |
| ONB5STF | Outer Diameter 5 mm | In distribution |
| ONBFCA11ST | Outer Diameter 11 mm | In distribution |
| ONB11STF | Outer Diameter 11 mm | In distribution |
| 177772 | Outer Diameter 5 mm | In distribution |
| UNVCA11STF | Length,standard,N/A; | In distribution |
| ONB11LGF | Length,Long,N/A; | In distribution |
| NB5SHF | Outer Diameter 5 mm | In distribution |
| NB5STF | Outer Diameter 5 mm | In distribution |
| ONB12SHF | Length,Short,N/A; | In distribution |
| ONB5STF2C | Outer Diameter 5 mm | In distribution |
| 179101 | Outer Diameter 5 mm | In distribution |
| 177798 | Outer Diameter 12 mm | In distribution |
| 177770 | Outer Diameter 11 mm | In distribution |
| 179093F | Outer Diameter 5 mm | In distribution |
| UNVCA12STF | Outer Diameter 12 mm | In distribution |
| ONB5LGF | Length,Long,N/A; | In distribution |
| 179094F | Outer Diameter 5 mm | In distribution |
| 177092F | Outer Diameter 5 mm | In distribution |
| NB3SHFLP | length,short,N/A; | In distribution |
| 177792 | Outer Diameter 5 mm | In distribution |
| UNVCA12LGF | Greatest Diameter, 12MM; Length,Long,N/A; | In distribution |
| 177800 | Outer Diameter 11 mm | Withdrawn |
| 177790 | Outer Diameter 11 mm | Withdrawn |
| 177773 | Outer Diameter 5 mm | Withdrawn |
| 177991 | Outer Diameter 5 mm | Withdrawn |
| NB5STFLP | Outer Diameter 5 mm | Withdrawn |
| 177092 | Outer Diameter 5 mm | Withdrawn |
| ONBFCA12LG | Outer Diameter 12 mm | Withdrawn |
| 179093 | length,short,n/a; | Withdrawn |
| 177771 | Outer Diameter 12 mm | Withdrawn |
| NBFCA5ST | Outer Diameter 5 mm | Withdrawn |
| 177793 | Outer Diameter 5 mm | Withdrawn |
| NB5LGF | Length,Long,N/A; | Withdrawn |
| 177801 | Outer Diameter 5 mm | Withdrawn |
| 177799 | Length,Long,N/A; | Withdrawn |
| NBFCA5SH | Length,Short,N/A; | Withdrawn |
| 177990 | Outer Diameter 5 mm | Withdrawn |
| 177796 | Outer Diameter 10 mm | Withdrawn |
| 177791 | Outer Diameter 12 mm | Withdrawn |
| 179094 | Outer Diameter 5 mm | Withdrawn |
| ONBFCA5ST | Outer Diameter 5 mm | Withdrawn |
| 177093F | length,short,n/a; | Withdrawn |
| 177775 | Length,Long,N/A; | Withdrawn |
| 177794 | Outer Diameter 5 mm | Withdrawn |
| 177797 | Outer Diameter 10 mm | Withdrawn |
| 179100 | Outer Diameter 5 mm | Withdrawn |
| ONBFCA5SH | Outer Diameter 5 mm | Withdrawn |
| ONBFCA12ST | Outer Diameter 12 mm | Withdrawn |
| 177093 | Length,short,N/A; | Withdrawn |
| 177776 | Outer Diameter 10 mm | Withdrawn |
| ONBFCA5LG | Outer Diameter 5 mm | Withdrawn |
| NB5SHFLP | length,short,N/A; | 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
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2013-05-06 | Class II | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity | 2716 units | 2014-08-12 |
| Covidien | 510(k) number | 2013-05-06 | Class II | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity | 23050 units | 2014-08-12 |
| Covidien | 510(k) number | 2013-05-06 | Class II | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity | 126925 units | 2014-08-12 |
| Covidien | 510(k) number | 2013-05-06 | Class II | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity | 5364 units | 2014-08-12 |
| Covidien | 510(k) number | 2013-05-06 | Class II | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity | 2705 units | 2014-08-12 |
| Covidien | 510(k) number | 2013-05-06 | Class II | Device Design | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity | 57461 untis | 2014-08-12 |
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.