Single-Use Biopsy Valve (MAJ-1555)
FDA 510(k) clearance K251997 · decided 2025-09-25
Clearance details
- K-number
- K251997
- Device name
- Single-Use Biopsy Valve (MAJ-1555)
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-06-27
- Decision date
- 2025-09-25
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Olympus Medical Systems Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AUXILIARY WATER TUBE MAJ-855 (K251986) | Olympus Medical Systems Corporation | 2025-09-26 |
| ArgoCap (200.52) (K242586) | Ovesco Endoscopy AG | 2025-05-22 |
| Endoscopic Water Pump (K241704) | Hangzhou AGS MedTech Co., Ltd. | 2025-03-20 |
| Water Container (MAJ-901); Water Container (MAJ-902) (K242357) | Olympus Medical Systems Corporation | 2024-10-07 |
| Aspiration Catheter (2189) (K241874) | Hobbs Medical, Inc. | 2024-09-24 |
| ClearCap Distal Attachment (K242134) | Finemedix Co., Ltd. | 2024-08-20 |
| troCarWash™ System (K233442) | Biotex, Inc. | 2024-05-21 |
| Endoscopy Irrigation Tubing (K230773) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-11-21 |
| Air/Water Bottle Tubing, CO2 Source Tubing (K231471) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-09-08 |
| ENDOGATOR™ Hybrid Irrigation Tubing (K231418) | Medivators | 2023-08-14 |
| Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing (K231602) | Ga Health Company Limited | 2023-08-01 |
| ANDORATE® Valve Kit (K230932) | Ga Health Company Limited | 2023-07-07 |
Recalls involving this device
No recalls on record reference this clearance.