CPS
CPS Continuous Pressure Sensing Tubing SET With Filter
10manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
11recalls on this 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 | 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) | K983326 |
| Record published | 2016-09-24 |
| Record revised | 2023-11-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GS1013 | 10 | 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 |
|---|---|
| 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.