Cleared Special

K232951 - BioShield Biopsy Valve (00711124) (FDA 510(k) Clearance)

Also includes:
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)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232951 · Steris · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
29d
Days
Class 2
Risk

K232951 is an FDA 510(k) clearance for the BioShield Biopsy Valve (00711124). Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on October 20, 2023 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Steris devices

Submission Details

510(k) Number K232951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ODC Endoscope Channel Accessory

All 70
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K232951.
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