FDA 510(k)

HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000

K-Number: K982867 · 1999-02-19

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

Decision Date1999-02-19

Product CodeHIG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 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 1999-02-19 under 510(k) number K982867. 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 HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000?

HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 is a medical device that received FDA 510(k) clearance on 1999-02-19. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K982867.

When did HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 receive FDA 510(k) clearance?

HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 received FDA 510(k) clearance on 1999-02-19, under 510(k) number K982867.

Who is the listed applicant for HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000?

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 HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000?

The FDA product code for HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 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.