FDA 510(k)

HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM

K-Number: K970078 · 1997-12-11

ApplicantDavol Inc., Sub. C. R. Bard, Inc.

Decision Date1997-12-11

Product CodeHIG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. It received FDA 510(k) clearance on 1997-12-11 under 510(k) number K970078. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM?

HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-11. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K970078.

When did HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM receive FDA 510(k) clearance?

HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM received FDA 510(k) clearance on 1997-12-11, under 510(k) number K970078.

Who is the listed applicant for HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM?

The FDA 510(k) record lists Davol Inc., Sub. C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM?

The FDA product code for HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM is HIG.

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Official Source

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