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Davol Hysteroscopy Pouch Drape And Tubing Set, Model Ooxxxxo

by Davol Inc., Sub. C. R. Bard, Inc.

510(k) K991799

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991799 Date13 Sep 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HIG
Device Class
Class II
Regulation
21 CFR Part 884.1700
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Davol Hysteroscopy Pouch Drape And Tubing Set, Model Ooxxxxo, is a hysteroscopic insufflator used for the collection of distention and irrigation fluids during diagnostic or operative hysteroscopy. It consists of a blue polyethylene under-buttocks drape with a clear funnel-shaped fluid collection pouch and fluid collection tubing set.

The device is supplied with a patient adhesive strip, hand cuffs for positioning, and a malleable wire support. It is classified as a Class II device with the product code HIG, and has been cleared by the FDA with the K number K991799. The device is intended for use in obstetrics and gynecology settings.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Davol Hysteroscopy Pouch Drape And Tubing Set used for?

    The Davol Hysteroscopy Pouch Drape And Tubing Set is used for collecting distention and irrigation fluids during diagnostic or operative hysteroscopy, and is intended for use in obstetrics and gynecology settings.

  • What components are included with the device?

    The device is supplied with a patient adhesive strip, hand cuffs for positioning, and a malleable wire support, in addition to the blue polyethylene under-buttocks drape and fluid collection tubing set.

  • Is the Davol Hysteroscopy Pouch Drape And Tubing Set a single-use or reusable device?

    The description does not explicitly state whether the device is single-use or reusable, but it is classified as a Class II device with a specific product code and has been cleared by the FDA.

  • What is the regulatory status of the Davol Hysteroscopy Pouch Drape And Tubing Set?

    The device has been cleared by the FDA with the K number K991799, and is classified as a Class II device with the product code HIG.