BioShield Biopsy Valve (00711124) +11 more— 510(k) K232951

Name: FDA 510(k) clearance K232951
Creator: U.S. Food and Drug Administration
Published: 2023-10-20

Substantially Equivalent

Steris

FDA 510(k) clearance K232951 for BioShield Biopsy Valve (00711124) +11 more, Substantially Equivalent on 2023-10-20. Applicant: Steris. Device class: 2.

Clearance details

Device name as filed: 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
Product code: Product code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-09-21
Decision date: 2023-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.