Airseal
The AirSeal iFS System is intended for diagnostic or therapeutic endoscopic procedures. It distends a cavity with gas, maintains a gas-sealed access path for instruments and evacuates…
The AirSeal iFS System is intended for diagnostic or therapeutic endoscopic procedures. It distends a cavity with gas, maintains a gas-sealed access path for instruments and evacuates surgical smoke.
The listed use areas include abdominal, thoracic and pediatric procedures where insufflation is desired. The filing describes the AirSeal system family alongside its dV solution.
Listed Item
AirSeal Bifurcated Filtered Tubeset with Activated Charcoal Filter
Procedure Context
The filing describes insufflation, AirSeal and smoke-evacuation modes. Its listed uses include abdominal, thoracic and pediatric procedures where insufflation is desired.
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 | ConMed Corporation, United States |
|---|---|
| FDA product code | HIF |
| Device type | Insufflator, Laparoscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1730 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K230239 |
| Record published | 2024-03-27 |
| Record revised | 2024-08-02 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 32 °C; Storage environment temperature 50 to 90 °F |
| Packaging | Box of 6, box, box of 10 |
| Distribution end date | 2026-03-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SEM-EVAC | 6 | In distribution | |
| ASM-EVAC1 | 6 | In distribution | |
| AS-IFS2 | In distribution | ||
| ASM-EVAC1-Bi | 6 | In distribution | |
| AS-iFS1 | In distribution | ||
| ASM-EVAC | 6 | Withdrawn | |
| AS-iFS1 | Withdrawn | ||
| AS-iFS2 | Withdrawn | ||
| SEM-EVAC | 6 | Withdrawn | |
| SIM-TUB | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comeg Medical | Sopro | 20 |
| Insufflator, Laparoscopic | Richard Wolf Gmbh | 19 |
| 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 |
| Smith & Nephew 400 | Smith & Nephew, Inc. | 6 |
Showing 12 of 114. All products under Insufflator, Laparoscopic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230239 | 2023-09-20 |
| K211104 | 2021-08-19 |
| K190303 | 2019-03-28 |
| K172516 | 2018-03-16 |
Recalls
11 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 3,550 packs (21,300 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 55,694 packs (344,166 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 1,668 packs (10,005 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 891 packs (5,346 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 36,462 packs (219,850 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 147,013 packs (882,078 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 71,151 packs (426,908 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 32,792 packs (196,751 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 1,261 packs (7,566 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 26,609 packs (159,657 eaches) |
| 2026-05-14 | Class II | Process change control | Potential for overpressure alerts. | 497 packs (2,982 eaches) |
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.