Insuflow Synergy Port
5mm GAS CONDITIONING PORT
10manufacturers in China registered for this device type
1catalogue number
12510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Unimicro Medical Systems (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Tianjin Uwell Medical Device Manufacturing Co Ltd | Tianjin | Tianjin | Manufacturer | 3 |
Record
| Listed by | Lexion Medical, LLC., United States |
|---|---|
| FDA product code | HIF |
| Device type | Insufflator, Laparoscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1730 |
| Establishment | Manufacturer |
| Record published | 2017-02-15 |
| Record revised | 2023-06-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2020-01-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1991 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comeg Medical | Sopro | 20 |
| Insufflator, Laparoscopic | Richard Wolf Gmbh | 19 |
| Airseal | ConMed Corporation | 10 |
| Insufflator, Laparoscopic | Smith & Nephew, Inc. | 10 |
| Gimmi | Gimmi Gmbh | 8 |
| Insuflow Port | Lexion Medical, LLC. | 8 |
| Aesculap | Aesculap AG | 7 |
| Insufflator, Laparoscopic | Stryker GmbH | 6 |
| EVA15 | Palliare | 6 |
| Conmed | ConMed Corporation | 6 |
| Pneumosure | Stryker GmbH | 6 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 6 |
Showing 12 of 114. All products under Insufflator, Laparoscopic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191780 | 2019-08-28 |
| K170799 | 2017-11-14 |
| K140263 | 2014-03-05 |
| K132203 | 2013-09-20 |
| K132204 | 2013-08-22 |
| K120640 | 2012-07-18 |
| K112357 | 2011-11-10 |
| K102136 | 2010-09-27 |
| K101320 | 2010-06-24 |
| K091366 | 2009-09-03 |
| K090456 | 2009-08-26 |
| K063546 | 2007-01-10 |
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.