DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
FDA 510(k) clearance K242742 · decided 2024-10-11
Clearance details
- K-number
- K242742
- Device name
- DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-09-11
- Decision date
- 2024-10-11
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- ODC
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| DYNE PORT (K252933) | Dyne Medical Group, Inc. | 2026-06-12 |
| Biopsy Port Adapter (K250145) | Endosound, Inc. | 2025-10-17 |
| Orca Air/Water and Suction Valves (K252910) | Boston Scientific | 2025-10-09 |
| Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (K250949) | Olympus Medical Systems Corporation | 2025-07-16 |
| Disposable Endoscopy Valve Set (K250732) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2025-06-20 |
| Luer-Split MAJ-2092 (K241842) | Olympus Medical Systems Corporation | 2025-03-19 |
| Defendo Fujifilm 700 Single Use Cleaning Adapter (K250140) | Steris Corparation | 2025-02-20 |
| Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (K243075) | STERIS Corporation | 2024-11-08 |
| Disposable Endoscope Valves Set (AF series) (K241285) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-10-01 |
| 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 (K232067) | Medivators (A Subsidiary of Steris Corporation) | 2024-03-22 |
| Endorail (K232327) | Endostart S.R.L. | 2024-03-15 |
| Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector (K232004) | Medivators (A Subsidiary of Steris Corporation) | 2024-03-06 |
Recalls involving this device
No recalls on record reference this clearance.