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)
by Steris
510(k) K232951
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232951 | Date20 Oct 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ODC
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The BioShield Biopsy Valve and related accessories are classified as Endoscope Channel Accessories, designed to cover the biopsy/suction channel inlet of gastrointestinal (GI) endoscopes. These devices facilitate controlled access for endoscopic instruments, ensuring proper function during biopsy or suction procedures while maintaining channel integrity.
The BioShield Biopsy Valve and associated components are intended for single-use in clinical settings, including gastroenterology and urology. They are supplied sterile or non-sterile as specified, with models compatible for use with Olympus/Fujifilm endoscopes. The devices are regulated under FDA 510(k) clearance (K232951) and fall under classification II (876.1500), adhering to infection control guidelines for reusable endoscope channels.
Other devices from Steris Corporation
Questions
AI-generated answers, 19 Sep 2026
Are these BioShield devices compatible with Olympus or Fujifilm endoscopes, and how do I confirm the correct model for my scope?
Yes, the BioShield Biopsy Valve and related accessories are explicitly designed for use with Olympus and Fujifilm endoscopes. While the device data does not specify exact scope models, the compatibility is noted in the description. To ensure the correct model, verify the channel size of your endoscope and cross-reference it with the available BioShield Biopsy Valve models (e.g., 00711124, 00711125, etc.). The manufacturer, Steris, can also provide guidance if needed.
Are the BioShield Biopsy Valve and its accessories single-use or reusable, and how should they be handled post-procedure?
The BioShield Biopsy Valve and its accessories, including the irrigator, irrigating adaptor, and extension tubing, are explicitly intended for single-use only in clinical settings. After use, they should be discarded according to infection control guidelines for reusable endoscope channels, as they are not designed for reprocessing. This aligns with the device’s classification as an endoscope channel accessory and its intended use in gastroenterology and urology.
Which models of the BioShield Biopsy Valve are sterile, and how should I store them before use?
The BioShield Biopsy Valve - sterile (00711128) is the only model explicitly labeled as sterile. The other models (e.g., 00711124, 00711125) are non-sterile. Sterile models should be stored in their original packaging until use, following the manufacturer’s instructions to maintain sterility. Non-sterile models should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, as per standard single-use medical device storage practices.
What is the regulatory pathway for these devices, and how can I verify their compliance status?
The BioShield Biopsy Valve and related accessories are regulated under FDA 510(k) clearance (K232951) and classified under FDA classification II (876.1500) as Endoscope Channel Accessories. The clearance was granted under a Special 510(k) process, with the decision dated October 20, 2023. To verify compliance, you can reference the FDA’s OpenFDA database using the provided FEI numbers or check the manufacturer’s documentation, as these devices are intended for use in the U.S. under this regulatory route.