Insuflow Port
Insuflow Port combines an endoscopic instrument access port with a gas conditioning pathway. It connects to the Lexion AP50/30 insufflator to filter, warm and humidify carbon dioxide before…
Insuflow Port combines an endoscopic instrument access port with a gas conditioning pathway. It connects to the Lexion AP50/30 insufflator to filter, warm and humidify carbon dioxide before delivering the gas into the surgical cavity during minimally invasive procedures.
The port is intended for thoracic, abdominal and gynecologic endoscopic surgery. Its assembly includes a disposable tubing set and an access device containing pressure sensors, a filter and a heater/humidifier. A plug connector cable links pressure sensing, heating and safety circuits to the insufflator.
Listed Item
12mm x 130mm Insuflow Port
Gas Path and Supply
Gas passes through the in-line filter and tubing into the access device, where the heating element and humidification media condition it before delivery through the port lumen. The assembly is sterilized with ethylene oxide and intended for single use. Patient contact is limited to less than 24 hours.
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 |
| 510(k) | K170799 |
| Record published | 2020-11-05 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4100-8 | In distribution | |
| 4100-12B | In distribution | |
| 4100-10B | In distribution | |
| 4100-5 | In distribution | |
| 4100-10 | In distribution | |
| 4100-5B | In distribution | |
| 4100-12 | In distribution | |
| 4100-8B | In distribution |
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 |
| 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 |
| Smith & Nephew 400 | Smith & Nephew, 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.