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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)

K232951 Class II Special
Decision Date
2023-10-20
Sponsor / Applicant
Steris

Technical Specification

510(k) Submission ID K232951
Product Code ODC
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1500
Decision Date 2023-10-20
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

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) received FDA 510(k) clearance under submission number K232951, sponsored by Steris. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-10-20.

Classification & Regulation

This clearance is catalogued under FDA product code ODC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.