FDA 510(k)

BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138

K-Number: K070420 · 2007-03-19

ApplicantUnited States Endoscopy Group, Inc.

Decision Date2007-03-19

Product CodeODD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2007-03-19 under 510(k) number K070420. The device is classified under product code ODD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138?

BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 is a medical device that received FDA 510(k) clearance on 2007-03-19. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K070420.

When did BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 receive FDA 510(k) clearance?

BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 received FDA 510(k) clearance on 2007-03-19, under 510(k) number K070420.

Who is the listed applicant for BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138?

The FDA product code for BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 is ODD.

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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.