510(k) K213991
- Device
- Enbio S
- Applicant
- Enbio Group AG
- 510(k) number
- K213991
- Product code
- FLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-02-22
- Date received
- 2021-12-21
- Regulation
- 880.6880
- Classification name
- Sterilizer, Steam
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lukasz Rogowski
- Address
- Eichengasse 3 Oensingen CH CH-4702 CH-4702
FDA Registration Numbers#
- 3005899764
- 1220246
- 8030087
- 1926681
- 3015729
- 3010653034
- 3016777357
- 3010446656
- 1523530
- 3015207155
- 3023861999
- 3009685834
- 3022516928
- 1219189
- 9610612
- 2518157
- 2126663
- 3015231789
- 8043629
- 2916714
- 3002579136
- 3005544459
- 3030597797
- 2435367
- 3005180920
- 3038718579
- 1036362
- 3027434168
- 8010652
- 1825014
- 3025308469
- 1017522
- 3001061128
- 3016851379
- 3006610845
- 3013596742
- 3012068831
- 3044322716
- 3008110533
- 3013176080
- 3003934980
- 3010684578
- 3008342949
- 3011824442
- 3011421558
- 3010331645
- 3035366890
- 3013300766
- 3012421607
- 3007515605
- 3018815412
- 9680353
- 1932355
- 3017125427
- 3003947740
- 3007279848
- 3015376465
- 3031563141
- 3009519707
Source Documents#
Other 510(k) Records For Product Code FLE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260254 | Enbio PRO | Enbio Group AG | 2026-02-26 |
| K252307 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | 2026-01-22 |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | 2025-12-30 |
| K250164 | Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2025-08-14 |
| K243994 | Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. | 2025-06-06 |
| K243801 | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | 2025-03-07 |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation | 2024-04-04 |
| K233504 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2024-02-08 |
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | 2023-12-19 |
| K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023-11-27 |
| K232485 | AMSCO 600 Steam Sterilizer | Steris | 2023-09-13 |
| K231489 | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | 2023-06-21 |
| K223858 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2023-05-05 |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023-02-10 |
| K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | Steelco S.P.A. | 2023-02-02 |