Decision Date1991-04-25
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
BARD 3000 PLUS URETEROSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1991-04-25 under 510(k) number K911411. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BARD 3000 PLUS URETEROSCOPY SYSTEM?
BARD 3000 PLUS URETEROSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K911411.
When did BARD 3000 PLUS URETEROSCOPY SYSTEM receive FDA 510(k) clearance?
BARD 3000 PLUS URETEROSCOPY SYSTEM received FDA 510(k) clearance on 1991-04-25, under 510(k) number K911411.
Who is the listed applicant for BARD 3000 PLUS URETEROSCOPY SYSTEM?
The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BARD 3000 PLUS URETEROSCOPY SYSTEM?
The FDA product code for BARD 3000 PLUS URETEROSCOPY SYSTEM is FGB.
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Official Source
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