Cleared Special

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 · Steris · Gastroenterology & Urology

Oct 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K232951 is an FDA 510(k) clearance for the 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), a Endoscope Channel Accessory (Class II — Special Controls, product code ODC), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on October 20, 2023, 29 days after receiving the submission on September 21, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K232951 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2023
Decision Date	October 20, 2023
Days to Decision	29 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	ODC — Endoscope Channel Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Give The Endoscope Channel Additional Or Improved Functionality.