510(k) K251997
- Device
- Single-Use Biopsy Valve (MAJ-1555)
- Applicant
- Olympus Medical Systems Corporation
- 510(k) number
- K251997
- Product code
- OCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-25
- Date received
- 2025-06-27
- Regulation
- 876.1500
- Classification name
- Endoscopic Irrigation/Suction System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jillian Connery
- Address
- 2951 Ishikawa-Cho Hachioji-Shi JP 192-8507 192-8507
FDA Registration Numbers#
- 1722746
- 3015173212
- 2029275
- 3009106214
- 3011193403
- 2528981
- 2243757
- 2244478
- 1216677
- 3010288205
- 1423662
- 1651395
- 3007389669
- 3004167615
- 3000974800
- 3002807314
- 1000121056
- 8010047
- 3011050570
- 3010202439
- 1047843
- 3020712480
- 1018233
- 3010612620
- 3013348547
- 3009538961
- 3004519921
- 3010149039
- 9616684
- 3005580113
- 9614434
- 2183446
- 3010273872
- 3003790304
- 2124215
- 1221826
- 9611590
- 3004111573
- 9611174
- 1037905
- 1643817
- 1649518
- 2020550
- 3002808148
- 3004530184
- 9610595
- 3010230734
- 3011219572
- 3010383847
- 1650907
- 2518897
- 3016678045
- 9610614
- 1320894
- 2246552
- 3008720584
- 3033589330
- 3009217531
- 3005099803
- 3017907746
- 1220592
- 1417592
- 3005726841
- 3003207991
- 3021023752
- 3032507796
- 1000393132
- 9611680
- 3005245797
- 3015225571
- 3006082230
- 3013460719
- 1528319
- 9681260
- 2183744
- 3004762958
- 3014749926
- 3012322232
- 3015309643
Source Documents#
Other 510(k) Records For Product Code OCX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation | 2025-09-26 |
| K242586 | ArgoCap (200.52) | Ovesco Endoscopy AG | 2025-05-22 |
| K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | 2025-03-20 |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | Olympus Medical Systems Corporation | 2024-10-07 |
| K241874 | Aspiration Catheter (2189) | Hobbs Medical, Inc. | 2024-09-24 |
| K242134 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2024-08-20 |
| K233442 | troCarWash™ System | Biotex, Inc. | 2024-05-21 |
| K230773 | Endoscopy Irrigation Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-11-21 |
| K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-09-08 |
| K231418 | ENDOGATOR™ Hybrid Irrigation Tubing | Medivators | 2023-08-14 |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | Ga Health Company Limited | 2023-08-01 |
| K230932 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023-07-07 |
| K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | Saneso, Inc. | 2023-02-27 |
| K222695 | troCarWash™ System | Biotex, Inc. | 2023-02-17 |
| K223171 | AquaPulse® Irrigation Tubing | Ga Health Company Limited | 2022-11-10 |