BioShield biopsy valve EUS - Linear— 510(k) K202583
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K202583 for BioShield biopsy valve EUS - Linear, Substantially Equivalent on 2020-11-06. Applicant: STERIS Corporation. Device class: 2.
Clearance details
- Applicant
- STERIS Corporation
- Product code
- Code ODD
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Recent devices under product code ODD
view all- K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
- K171989 — Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
- K070420 — BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
- K011149 — DISPOSABLE BENDING CANNULA PR-233Q
- K010993 — ALIEN RX MICRO CANNULA, MODEL 4530
More clearances from STERIS Corporation
view allData sourced from openFDA. This site is unofficial and independent of the FDA.