Ideal Eyes
HD IR Bariatric Infrared Laparoscope, Autoclavable, Full Screen, 30 View Direction
46manufacturers in China registered for this device type
27catalogue numbers in this listing
20510(k) clearances naming this product 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2023-01-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Moist Heat or Steam Sterilization, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 15 to 90 % RH; Storage environment temperature -18 to 60 °C |
| Sizes | Outer diameter 2.9 to 10 mm; length 30 cm |
| Distribution end date | 2023-03-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0502540030 | Outer Diameter 5.0 mm | In distribution |
| 0502211030 | Outer Diameter 10.0 mm | In distribution |
| 0502290030 | Outer Diameter 2.9 mm | In distribution |
| 0502205010 | Outer Diameter 5.0 mm | In distribution |
| 0502210045 | Outer Diameter 10.0 mm | In distribution |
| 0502329030 | Length 30.0 cm | In distribution |
| 0502860030 | Outer Diameter 10.0 mm | In distribution |
| 0502205030 | Outer Diameter 5.0 mm | In distribution |
| 0502860010 | Outer Diameter 10.0 mm | In distribution |
| 0502540045 | Outer Diameter 5.0 mm | In distribution |
| 0502206030 | Outer Diameter 5.0 mm | In distribution |
| 0502860045 | Outer Diameter 10.0 mm | In distribution |
| 0502329010 | Outer Diameter 2.9 mm | In distribution |
| 0502540010 | Outer Diameter 5.0 mm | In distribution |
| 0502539045 | Outer Diameter 5.0 mm | In distribution |
| 0502290010 | Outer Diameter 2.9 mm | In distribution |
| 0502206010 | Outer Diameter 5.0 mm | In distribution |
| 0502211045 | Outer Diameter 10.0 mm | In distribution |
| 0502210030 | Outer Diameter 10.0 mm | In distribution |
| 0502210010 | Outer Diameter 10.0 mm | In distribution |
| 0502205045 | Outer Diameter 5.0 mm | In distribution |
| 0502206045 | Outer Diameter 5.0 mm | In distribution |
| 0502859045 | Outer Diameter 10.0 mm | In distribution |
| 0502859010 | Outer Diameter 10.0 mm | Withdrawn |
| 0502539030 | Outer Diameter 5.0 mm | Withdrawn |
| 0502859030 | Outer Diameter 10.0 mm | Withdrawn |
| 0502539010 | Outer Diameter 5.0 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 |
|---|---|
| K232157 | 2023-08-18 |
| K230605 | 2023-03-31 |
| K230216 | 2023-02-23 |
| K222130 | 2022-08-19 |
| K221217 | 2022-06-17 |
| K214046 | 2022-05-25 |
| K220895 | 2022-04-22 |
| K212055 | 2021-12-16 |
| K212511 | 2021-11-04 |
| K210088 | 2021-04-13 |
| K210584 | 2021-03-18 |
| K202592 | 2020-10-08 |
| K201434 | 2020-07-28 |
| K200310 | 2020-03-06 |
| K192172 | 2019-09-09 |
| K181258 | 2018-11-05 |
| K182160 | 2018-11-05 |
| K930224 | 1994-06-30 |
| K934094 | 1994-02-18 |
| K910132 | 1991-02-21 |
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.