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MIC Specific Line Replacement Kit

by Medical Innovations Corp.

510(k) K880768

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880768 Date22 Apr 1988ClearedStatusActive

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  • Withdrawn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 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The MIC Specific Line Replacement Kit is a Tubes, Gastrointestinal (and Accessories) device, designed for use in gastrointestinal and urological procedures. It serves as a replacement component for existing endoscopic or diagnostic tubing systems, ensuring compatibility with specific medical lines. The kit is intended for sterile, single-use applications in controlled clinical settings where precise tubing integrity is required.

This kit is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K880768) with a classification under Product Code KNT. It was reviewed by the Gastroenterology/Urology advisory committee and is intended for use in procedures requiring gastrointestinal or urological tubing replacements. Storage and handling must adhere to sterile medical device protocols to maintain functionality and safety.

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Questions

AI-generated answers, 1 Oct 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 MIC Specific Line Replacement Kit used for?

    The MIC Specific Line Replacement Kit is designed to replace tubing components in existing endoscopic or diagnostic systems used during gastrointestinal and urological procedures. It ensures seamless integration with compatible medical lines, maintaining procedural integrity where precise tubing functionality is critical.

  • Is the MIC Specific Line Replacement Kit sterile and single-use?

    Yes, the kit is supplied sterile and intended for single-use only. This design minimizes contamination risks and ensures patient safety in controlled clinical settings, adhering to sterile medical device protocols.

  • What types of procedures can this replacement kit be used in?

    The kit is intended for procedures requiring gastrointestinal or urological tubing replacements, such as endoscopies or diagnostic evaluations where tubing integrity is essential. It is not intended for general surgical or non-specific medical applications.

  • How should the MIC Specific Line Replacement Kit be stored?

    The kit must be stored according to sterile medical device protocols to preserve its functionality and safety. This includes maintaining the sterile barrier, protecting from physical damage, and following manufacturer guidelines to prevent contamination before use.

  • What regulatory approval does this replacement kit have?

    The MIC Specific Line Replacement Kit holds FDA 510(k) clearance under the reference number K880768, classified under Product Code KNT. It was reviewed by the Gastroenterology/Urology advisory committee and is intended for use in specific medical contexts as outlined in its regulatory submission.