K232951
- 510(k) number
- K232951
- Device name
- BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)
- Applicant
- Steris OH · US
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2023-10-20
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232951.pdf
Official FDA record: K232951
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.