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BioGuard Air/Water and Suction Valves

by Steris Corporations

510(k) K203630

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK203630 Date8 Jan 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ODC
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BioGuard Air/Water and Suction Valves are classified as Endoscope Channel Accessories, designed to regulate airflow, water flow, and suction within endoscope channels. These valves prevent contamination by ensuring unidirectional flow, reducing the risk of cross-contamination during gastrointestinal and urological procedures. They are engineered to integrate with endoscope systems, maintaining procedural integrity while minimizing manual intervention.

These valves are supplied as single-use, disposable devices in kit configurations (2-, 3-, or 4-piece) and are intended for use in sterile environments such as endoscopy suites. Compatible with MRI-safe endoscope systems, they adhere to infection prevention guidelines and eliminate the need for manual cleaning or reprocessing. The devices are regulated under FDA 510(k) clearance (K203630) and fall under Class II medical device classification (876.1500). Proper storage requires maintaining sterility until first use.

Other devices from Steris Corporations

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the BioGuard Air/Water and Suction Valves designed to do?

    These valves regulate airflow, water flow, and suction within endoscope channels to prevent contamination. By ensuring unidirectional flow, they minimize the risk of cross-contamination during gastrointestinal and urological procedures, maintaining procedural integrity without manual intervention.

  • Are these valves compatible with MRI-safe endoscope systems?

    Yes, the BioGuard Air/Water and Suction Valves are explicitly designed to integrate with MRI-safe endoscope systems. This compatibility ensures they can be safely used in environments where MRI imaging is required without interference.

  • How are these valves supplied, and what does the kit include?

    The valves are supplied as single-use, disposable devices in kit configurations containing either 2, 3, or 4 pieces. This ensures convenience for sterile environments like endoscopy suites, eliminating the need for manual cleaning or reprocessing.

  • Why are these valves considered single-use, and what does that mean for infection control?

    These valves are designed as single-use to eliminate the risk of cross-contamination between patients. Since they are disposable, there is no need for reprocessing, which simplifies infection control protocols and adheres to strict sterile environment guidelines.

  • How should these valves be stored to maintain sterility?

    The valves must be stored in their original packaging until the first use to ensure sterility is maintained. Proper storage conditions prevent contamination and preserve the device’s integrity for safe procedural use.