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Dextran HM 32% Hysteroscopic Distention Medium

FDA PMA

Class III (US FDA PMA)

PMA P880028

by Hospira, Inc.

Identity

Trade Name
DEXTRAN HM 32% FDA PMA
Generic Name
FLUID, HYSTEROSCOPY FDA PMA

Identifiers

PMA Number
P880028 FDA PMA
FDA Product Code
LTA FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Obstetrics/Gynecology FDA PMA
FDA Decision
APWD FDA PMA

This device is a Fluid, Hysteroscopy, classified as a Class III medical device under FDA regulations. It serves as a distention medium used during hysteroscopic procedures to expand the uterine cavity, improving visualization and access for diagnostic or therapeutic interventions.

The medium is supplied as a sterile, single-use solution for intrauterine application. It is intended for use in clinical settings where hysteroscopy is performed, adhering to standard aseptic techniques. Authorized under FDA_PMA (PMA Number: P880028), it is regulated under the Obstetrics/Gynecology advisory committee category and supplied in a premeasured, ready-to-use format.

Frequently asked questions

What is DEXTRAN HM 32% used for during a hysteroscopic procedure?

DEXTRAN HM 32% is a distention medium specifically designed to expand the uterine cavity during hysteroscopy. This creates better visualization and improved access for the surgeon, making it easier to perform diagnostic or therapeutic interventions safely and effectively.

Is DEXTRAN HM 32% sterile and single-use? How is it supplied?

Yes, DEXTRAN HM 32% is supplied as a sterile, single-use solution. It comes premeasured and ready-to-use, ensuring convenience and adherence to aseptic techniques in clinical settings where hysteroscopy is performed.

How is this product regulated, and what does that mean for its use?

DEXTRAN HM 32% is classified as a Class III medical device under FDA regulations and is authorized through a Premarket Approval (PMA) process (PMA Number: P880028). This means it has undergone rigorous review by the FDA’s Obstetrics/Gynecology advisory committee to ensure safety and effectiveness for intrauterine use during hysteroscopic procedures.

Can this product be reused, or is it intended for one-time use only?

DEXTRAN HM 32% is explicitly intended for single-use only. The sterile, premeasured format ensures it remains uncontaminated for one procedure, aligning with best practices for patient safety and infection control in clinical settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Hospira, Inc.

Sources (1)

  • FDA PMA P880028 24 fields · synced Sep 18, 2026