FDA 510(k)

BARD IRYFIX(TM) STOMA CAP

K-Number: K862631 · 1986-10-16

Decision Date1986-10-16

Product CodeEXB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BARD IRYFIX(TM) STOMA CAP 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 1986-10-16 under 510(k) number K862631. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD IRYFIX(TM) STOMA CAP?

BARD IRYFIX(TM) STOMA CAP is a medical device that received FDA 510(k) clearance on 1986-10-16. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K862631.

When did BARD IRYFIX(TM) STOMA CAP receive FDA 510(k) clearance?

BARD IRYFIX(TM) STOMA CAP received FDA 510(k) clearance on 1986-10-16, under 510(k) number K862631.

Who is the listed applicant for BARD IRYFIX(TM) STOMA CAP?

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 IRYFIX(TM) STOMA CAP?

The FDA product code for BARD IRYFIX(TM) STOMA CAP is EXB.

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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.