Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor

K-Number: K210342 · 2021-09-03

ApplicantSTERIS Corporation
Decision Date2021-09-03
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K210342. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is STERIS Corporation. The 510(k) number is K210342.

When did BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor receive FDA 510(k) clearance?

BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor received FDA 510(k) clearance on 2021-09-03, under 510(k) number K210342.

Who is the listed applicant for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

The FDA product code for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor is ODC.

Other records listing STERIS Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261055AMSCO 700 Steam SterilizerK260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K252680Celerity™ 20 HP Biological IndicatorK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

View all 139 devices →

Related Devices (Code: ODC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑