510(k) K232329
- Device
- Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
- Applicant
- Medivators (A Subsidiary of Steris Corporation)
- 510(k) number
- K232329
- Product code
- ODC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-21
- Date received
- 2023-08-03
- Regulation
- 876.1500
- Classification name
- Endoscope Channel Accessory
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Nick Wang
- Address
- 3150 Pollok Dr. Conroe TX US 77303 77303
FDA Registration Numbers
- 3008573567
- 2024311
- 3006621103
- 3011193403
- 1056553
- 2528981
- 3010288205
- 1423662
- 1651395
- 3010400865
- 3000974800
- 3002807314
- 1000121056
- 8010047
- 3011050570
- 1047843
- 3010612620
- 3028058843
- 3007014520
- 9611102
- 9616684
- 3004837686
- 3005580113
- 3005261802
- 3011707784
- 3017911818
- 2183446
- 3010273872
- 3003790304
- 3015970743
- 3003903031
- 2124215
- 3004111573
- 3009064553
- 1825146
- 1037905
- 3010408671
- 3002808148
- 1820334
- 3009763019
- 9610595
- 3010230734
- 9614279
- 1650907
- 2518897
- 3007789561
- 1828132
- 1320894
- 2246552
- 3025347444
- 3002808022
- 3005099803
- 3026121953
- 3003207991
- 3021023752
- 3032507796
- 1000393132
- 3013460719
- 1528319
- 3006787036
- 9681260
- 2032098
- 3022106566
- 3014749926
- 3008797804
- 1418479
- 3008058134
- 3017968993
- 9610877
- 3018116884
- 2027111
- 3008048800
- 3003782610
- 3009051888
- 3013440400
- 3020707080
- 3021349683
- 3017262662
- 3013023255
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 50724995228960 | DEFENDO | MEDIVATORS INC. | 2024-01-18 |
| 50724995228953 | DEFENDO | MEDIVATORS INC. | 2024-01-18 |
| 50724995228946 | DEFENDO | MEDIVATORS INC. | 2024-01-18 |
| 50724995228939 | DEFENDO | MEDIVATORS INC. | 2024-01-18 |
| 50724995228922 | DEFENDO | MEDIVATORS INC. | 2024-01-18 |
| 50724995228915 | DEFENDO | MEDIVATORS INC. | 2024-01-18 |
| 50724995228908 | DEFENDO | MEDIVATORS INC. | 2024-01-18 |
Other 510(k) Records For Product Code ODC
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250145 | Biopsy Port Adapter | Endosound, Inc. | 2025-10-17 |
| K252910 | Orca Air/Water and Suction Valves | Boston Scientific | 2025-10-09 |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corporation | 2025-07-16 |
| K250732 | Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2025-06-20 |
| K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | 2025-03-19 |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | 2025-02-20 |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | STERIS Corporation | 2024-11-08 |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | 2024-10-11 |
| K241285 | Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-10-01 |
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | 2024-03-22 |
| K232327 | Endorail | Endostart S.R.L. | 2024-03-15 |
| K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | STERIS Corporation | 2024-03-06 |
| K232004 | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | 2024-03-06 |
| K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | 2024-02-09 |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | Pentax of America, Inc. | 2023-12-01 |