Espiner Tissue Retrieval System
Laparoscopic tissue retrieval sac for use with minimally invasive procedures.
46manufacturers in China registered for this device type
58catalogue numbers in this listing
1510(k) clearance
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 | Espiner Medical Limited, United Kingdom |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K111845 |
| Record published | 2016-09-23 |
| Record revised | 2024-06-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, box of 5, box of 50, box of 20, box of 3, box of 6 |
| Sizes | Total volume 50 to 6000 ml; length 205 mm |
| Distribution end date | 2019-07-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EMP70-INS | Total Volume 60 ml | In distribution |
| EMP230ECO-US | Total Volume 3100 ml | In distribution |
| EMP600ECO | Total Volume 6000 ml | In distribution |
| EMP100ECO | Total Volume 200 ml | In distribution |
| EMP160-INS | Total Volume 900 ml | In distribution |
| EMP200ECO-R-10 | Total Volume 200 ml | In distribution |
| EMP80ECO-R | Total Volume 80 ml | In distribution |
| EMP100ECO-US | Total Volume 200 ml | In distribution |
| EMP110ECO-R | Total Volume 100 ml | In distribution |
| EMP180ECO-US | Total Volume 2000 ml | In distribution |
| EMP120-WG | Total Volume 550 ml | In distribution |
| EMP160ECO-US | Total Volume 1000 ml | In distribution |
| EMP70ECO-US | Total Volume 100 ml | In distribution |
| EMP175ECO-W | Total Volume 1900 ml | In distribution |
| EMP170ECO-US | Total Volume 1200 ml | In distribution |
| EMP145ECO | Total Volume 750 ml | In distribution |
| EMP140ECO | Total Volume 550 ml | In distribution |
| EMP80-WG | Total Volume 150 ml | In distribution |
| EMP140ECO-US | Total Volume 550 ml | In distribution |
| EMP230ECO | Total Volume 3100 ml | In distribution |
| EMP70ECO | Total Volume 100 ml | In distribution |
| EMP60ECO-R | Total Volume 60 ml | In distribution |
| EMP100-INS | Total Volume 200 ml | In distribution |
| EMP50ECO-R | Total Volume 50 ml | In distribution |
| EMP112-WG | Total Volume 400 ml | In distribution |
| EMP170ECO | Total Volume 1200 ml | In distribution |
| EMP100-WG | Total Volume 200 ml | In distribution |
| EMP160-WG | Total Volume 1500 ml | In distribution |
| EMP170-WG | Total Volume 1000 ml | Withdrawn |
| ECO60GREEN | Total Volume 80 ml | Withdrawn |
| EMP1215-TS | Length 205 mm | Withdrawn |
| EMP95ECO | Total Volume 190 ml | Withdrawn |
| EMP150ECOUS | Total Volume 750 ml | Withdrawn |
| EMP140ECO-S | Total Volume 550 ml | Withdrawn |
| ECO100GREEN | Total Volume 200 ml | Withdrawn |
| EMP70ECO-S | Total Volume 100 ml | Withdrawn |
| ECO71GREEN | Total Volume 100 ml | Withdrawn |
| EMP120-WGN | Total Volume 550 ml | Withdrawn |
| EMP80-INS-R | Total Volume 80 ml | Withdrawn |
| EMP200ECO | Total Volume 2500 ml | Withdrawn |
| EMP95-WG | Total Volume 190 ml | Withdrawn |
| ECO101GREEN | Total Volume 200 ml | Withdrawn |
| EMP150-WG | Total Volume 950 ml | Withdrawn |
| EMP180-WG | Total Volume 1800 ml | Withdrawn |
| EMP180ECO | Total Volume 2000 ml | Withdrawn |
| EMP240ECO-S | Total Volume 3650 ml | Withdrawn |
| EMP150ECO | Total Volume 750 ml | Withdrawn |
| EMP200ECO-US | Total Volume 2500 ml | Withdrawn |
| EMP130-INS | Total Volume 300 ml | Withdrawn |
| EMP100ECO-S | Total Volume 200 ml | Withdrawn |
| EMP160ECO-S | Total Volume 1000 ml | Withdrawn |
| ECO61GREEN | Total Volume 80 ml | Withdrawn |
| ECO70GREEN | Total Volume 100 ml | Withdrawn |
| EMP200-MN | Total Volume 3500 ml | Withdrawn |
| EMP160-MN | Total Volume 1050 ml | Withdrawn |
| ECO140GREEN | Total Volume 550 ml | Withdrawn |
| EMP90-MNT | Total Volume 150 ml | Withdrawn |
| EMP200WG | Total Volume 2000 ml | 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 |
|---|---|
| K111845 | 2011-09-26 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Fannin UK Ltd | 510(k) number | 2018-06-20 | Class II | Error in labeling | Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml | 230 units | 2019-12-09 |
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.