| K-number | K250145 |
| Device name | Biopsy Port Adapter |
| Applicant | Endosound, Inc. |
| Product code | ODC |
| Device class | Class II |
| Decision date | Oct 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The Biopsy Port Adapter (BPA) is a single-use device that converts the non-luer-lock biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port. It supports fine needle biopsy (FNB) and fine needle aspiration (FNA) procedures while maintaining scope suction capability and is used with the EndoSound Vision System for ultrasound-guided procedures.
The BPA shares similar technological characteristics with predicate devices: it attaches to an endoscope connector port to provide sealing and device passage. Compared to the BioShield Biopsy Valve (primary predicate), the BPA provides luer-lock conversion for upper GI endoscopes; compared to the Expect Pulmonary adapter, it adapts a non-luer port into a luer-type port for endoscopic (rather than bronchoscopic) use.
Not stated in this summary.
The BPA is substantially equivalent because it has the same intended use as predicates—providing a luer-lock for an endoscope connector port and sealing the biopsy/working channel—and demonstrates equivalent performance through nonclinical bench testing (lock/unlock force, suction, tensile strength, durability cycling, and packaging integrity). The differences in indications (upper GI vs. bronchoscopy) do not introduce new safety or effectiveness concerns, as demonstrated by comparative performance data and risk analysis.
View the full FDA submission: accessdata.fda.gov