Olympus Medical Systems Corporation · Class II · Cleared Sep 25, 2025
| K-number | K251997 |
| Device name | Single-Use Biopsy Valve (MAJ-1555) |
| Applicant | Olympus Medical Systems Corporation |
| Product code | OCX |
| Device class | Class II |
| Decision date | Sep 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The Single-Use Biopsy Valve (MAJ-1555) is a single-use accessory that attaches to the instrument channel port of endoscopes. It enables passage and exchange of endoscopic devices, maintains insufflation during procedures, minimizes leakage of biomaterial from the biopsy port, and provides access for irrigation. It is used by healthcare providers performing endoscopic procedures.
Not stated in this summary.
Not stated.
The device is a single-use biopsy valve designed to attach to standard endoscope instrument channels and perform functions comparable to existing predicate devices in this product category. The fundamental design, materials, and mechanism of action are consistent with legally marketed predicate biopsy valve accessories, and the single-use configuration does not raise new safety or effectiveness concerns relative to reusable equivalents.
View the full FDA submission: accessdata.fda.gov