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Flexi-Therm Film

by E-Z-Em, Inc. 510(k)

Active United States

510(k) K770986

Overview

The Flexi-Therm Film is a System, Thermographic, Liquid Crystal, Powered (Adjunctive Use) device designed for adjunctive monitoring in obstetrics and gynecology. It utilizes liquid crystal technology to provide visual temperature mapping, aiding in the assessment of thermal patterns during medical procedures.

This device is supplied as a single-use, non-sterile component intended for use in clinical settings where adjunctive thermal imaging is required. Cleared under FDA 510(k) (K770986) with Product Code KXZ, it falls under Device Class 3 and Regulation Number 884.2982. Storage and handling follow standard medical device protocols as outlined in the manufacturer’s instructions.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770986 Date12 Sep 1977ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KXZ
Device Class
Class III
Regulation
21 CFR Part 884.2982
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What clinical specialties is the Flexi-Therm Film primarily intended for adjunctive use in, and how does it function during procedures?

    The Flexi-Therm Film is designed for adjunctive use in obstetrics and gynecology, where it aids in visual temperature mapping using liquid crystal technology. It provides real-time thermal imaging to help clinicians assess thermal patterns during procedures, offering additional monitoring beyond standard methods.

  • Is the Flexi-Therm Film sterile, and how should it be handled to maintain its integrity?

    The Flexi-Therm Film is non-sterile and supplied as a single-use component. Since it is not sterile, it should be handled according to standard non-sterile medical device protocols as outlined in the manufacturer’s instructions to prevent contamination before use.

  • What regulatory pathway was followed for FDA clearance, and what classification does this device hold?

    The Flexi-Term Film was cleared through the traditional 510(k) pathway (K770986) and is classified as a Class 3 device under FDA regulation number 884.2982. The submission was reviewed by the Obstetrics/Gynecology advisory committee and determined to be substantially equivalent to a predicate device.

  • How is the Flexi-Therm Film supplied, and are there different sizes or models available?

    The Flexi-Term Film is supplied as a single-use, non-sterile component in a system designed for adjunctive thermal monitoring. While the provided data does not specify multiple sizes or models, its primary function is consistent across applications in obstetrics and gynecology, relying on liquid crystal technology for temperature visualization.