Getinge GSS610N Series Steam Sterilizer
Getinge GSS610N is a steam sterilizer for heat- and moisture-stable medical items such as surgical instruments and linens. It processes wrapped or unwrapped, porous or nonporous loads using…
Getinge GSS610N is a steam sterilizer for heat- and moisture-stable medical items such as surgical instruments and linens. It processes wrapped or unwrapped, porous or nonporous loads using pressurized steam.
The system offers gravity displacement and pressure-vacuum pulsing cycles for air removal. Its control system sequences and monitors the cycle phases and gives audible and visual notification when specified operating parameters deviate.
Chamber and Cycle Options
Models differ in chamber length and validated load capacity. Separate programmed cycles address instrument packs, fabric packs, test packs and specified vented-bottle loads, with exposure and drying conditions matched to the load. The selected cycle and loading pattern must correspond to the materials being processed and the validated configuration.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Ningbo Ican Machines Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Maquet Gmbh, Germany |
|---|---|
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K201927 |
| Record published | 2021-04-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 610N15 | In distribution | |
| 610N21 | In distribution | |
| 610N10 | In distribution | |
| 610N14 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amsco | Steris Mexico, S. de R.L. de C.V. | 434 |
| Getinge 500 Series | Getinge IC Production Poland sp. z o.o. | 133 |
| Getinge 700 Series | Getinge IC Production Poland sp. z o.o. | 82 |
| Aesculap | Aesculap AG | 67 |
| Getinge 600 Series | Getinge IC Production Poland sp. z o.o. | 61 |
| Sterilizer, Steam | Steris Mexico, S. de R.L. de C.V. | 53 |
| Getinge 800 Series | Getinge IC Production Poland sp. z o.o. | 41 |
| Getinge 400 Series | Getinge IC Production Poland sp. z o.o. | 37 |
| Primus Sterilizer | Primus Sterilizer Company, LLC. | 24 |
| Midmark | Midmark Corporation | 21 |
| Bravo 17V Autoclave | Scican Ltd. | 19 |
| Atlas | Steris Mexico, S. de R.L. de C.V. | 18 |
Showing 12 of 119. All products under Sterilizer, Steam
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K214120 | 2022-05-18 |
| K201927 | 2021-03-01 |
| K172159 | 2018-01-30 |
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.