Skip to content

Hyskon (32% Dextran 70)

by Coopervision Surgical

PMA N17511

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA N17511

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN17511 Date14 Dec 1981ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
FLUID, HYSTEROSCOPY
PMA Number
FDA Product Code
LTA
Device Class
Class III
Advisory Committee
Obstetrics/Gynecology
FDA Decision
APPR Approved
PMA Supplement
S001

Overview

AI-generated summary, 18 Sep 2026

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

Hyskón (32% Dextran 70) is a Fluid, Hysteroscopy classified under Device Class III, designed for use during hysteroscopic procedures. It functions as an irrigation medium to distend the uterine cavity, providing clear visualization of the endometrial lining and facilitating diagnostic or therapeutic interventions.

This sterile, single-use solution is supplied in a pre-filled container and is intended for obstetric and gynecologic settings. It adheres to FDA_PMA authorization (PMA Number: N17511) and is regulated under the Obstetrics/Gynecology advisory committee. Storage requires adherence to manufacturer guidelines for sterile solutions, and its use is restricted to qualified healthcare professionals in controlled clinical environments.

Other devices from Coopervision Surgical

Questions

AI-generated answers, 18 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 Hyskón (32% Dextran 70) used for during medical procedures?

    Hyskón (32% Dextran 70) is specifically designed as an irrigation medium for hysteroscopic procedures. It distends the uterine cavity to create clear visualization of the endometrial lining, enabling healthcare professionals to perform diagnostic evaluations or therapeutic interventions safely and effectively.

  • Is Hyskón (32% Dextran 70) intended for single-use or can it be reused?

    Hyskón (32% Dextran 70) is explicitly labeled as a **sterile, single-use** solution. This designation ensures patient safety by preventing contamination and maintaining sterility, which is critical for hysteroscopic procedures where cleanliness and sterility are paramount.

  • How should Hyskón (32% Dextran 70) be stored, and what are the key storage requirements?

    Hyskón (32% Dextran 70) must be stored according to the manufacturer’s guidelines for sterile solutions. Since it is pre-filled and sterile, it should remain unopened and protected from contamination until use. Proper storage conditions help preserve its integrity and effectiveness for hysteroscopic irrigation.

  • Who is authorized to use Hyskón (32% Dextran 70), and in what clinical settings?

    Hyskón (32% Dextran 70) is restricted for use by **qualified healthcare professionals** in controlled clinical environments, such as obstetrics and gynecology settings. Its design and regulatory classification (FDA_PMA) ensure it is only used in supervised medical procedures where hysteroscopy is performed.

  • What regulatory pathway does Hyskón (32% Dextran 70) follow, and how does that affect its availability?

    Hyskón (32% Dextran 70) follows the **FDA Pre-Market Approval (PMA) pathway**, with an approval decision dated October 14, 1982 (PMA Number: N17511). This pathway ensures rigorous evaluation before commercial distribution, confirming its safety and effectiveness for hysteroscopic irrigation. Availability is governed by FDA compliance and manufacturer distribution channels.