FDA 510(k)

BIPROBE(TM)

K-Number: K912601 · 1991-06-20

Decision Date1991-06-20

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BIPROBE(TM) 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 1991-06-20 under 510(k) number K912601. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIPROBE(TM)?

BIPROBE(TM) is a medical device that received FDA 510(k) clearance on 1991-06-20. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K912601.

When did BIPROBE(TM) receive FDA 510(k) clearance?

BIPROBE(TM) received FDA 510(k) clearance on 1991-06-20, under 510(k) number K912601.

Who is the listed applicant for BIPROBE(TM)?

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 BIPROBE(TM)?

The FDA product code for BIPROBE(TM) is KNS.

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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.