Insufflator
The Insufflator facilitates laparoscopic use by filling the peritoneal cavity with gas to distend it. The subject system comprises a CO2 insufflator, a high-pressure tube and a…
The Insufflator facilitates laparoscopic use by filling the peritoneal cavity with gas to distend it. The subject system comprises a CO2 insufflator, a high-pressure tube and a pneumoperitoneum tube.
Model SL101 includes a gas-heating function; SL102 does not. The filing also distinguishes pneumoperitoneum tubing with and without heating and tubing for central gas supply versus a gas cylinder.
Listed Item
The product is composed of a host and accessories (high pressure tube, pneumoperitoneum tube), and accessories are optional. The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
System Components
The insufflator is not intended to enter the sterile field. Its pneumoperitoneum tube must be cleaned, disinfected and sterilized before reuse; separate tubes are listed for central gas supply and a gas cylinder.
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 | Scivita Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | HIF |
| Device type | Insufflator, Laparoscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1730 |
| Establishment | Manufacturer |
| 510(k) | K222812 |
| Record published | 2024-02-28 |
| Record revised | 2025-06-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 20 to 80 % RH; Handling environment temperature 5 to 40 °C; Storage environment atmospheric pressure 40 to 106 KiloPascal; Storage environment humidity 20 to 90 % RH; Storage environment temperature -40 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SL101 | In distribution | |
| SL102 | 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 |
| 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 |
|---|---|
| K222812 | 2023-05-16 |
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.