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MIC (Specific Line) Insertion Kit

by Medical Innovations Corp.

510(k) K875126

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)SESD Substantially Equivalent — Deferred · Traditional NumberK875126 Date2 Mar 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  • Withdrawn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
SESD Substantially Equivalent — Deferred

Overview

AI-generated summary, 21 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 MIC (Specific Line) Insertion Kit is a device used for the insertion of specific lines, as indicated by its device name and specifications. It is manufactured by Medical Innovations Corp. and was cleared through the FDA 510(k) process under traditional clearance.

The device was submitted for review on December 15, 1987, and received clearance on March 2, 1988. It is associated with the Gastroenterology and Urology advisory committee (GU) and has the product code KNT and k-number K875126. No further details about sterility, single-use status, MRI safety, sizes, storage, or clinical indications are provided in the data.

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Questions

AI-generated answers, 21 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 MIC (Specific Line) Insertion Kit used for?

    The MIC (Specific Line) Insertion Kit is used for the insertion of specific lines, as indicated by its device name and specifications, though the exact clinical indication is not detailed in the provided data.

  • Who manufactures the MIC (Specific Line) Insertion Kit?

    The MIC (Specific Line) Insertion Kit is manufactured by Medical Innovations Corp., located at 1595 Mc-Candless Dr., Milpitas, CA 95035, United States.

  • How was the MIC (Specific Line) Insertion Kit cleared for market?

    The MIC (Specific Line) Insertion Kit received FDA clearance through the traditional 510(k) process, with submission received on December 15, 1987, and clearance granted on March 2, 1988.

  • What advisory committee and product code are associated with the MIC (Specific Line) Insertion Kit?

    The device is associated with the Gastroenterology and Urology (GU) advisory committee and has the product code KNT, as recorded in its FDA 510(k) submission.

  • What is the k-number for the MIC (Specific Line) Insertion Kit?

    The k-number for the MIC (Specific Line) Insertion Kit is K875126, which uniquely identifies this device in the FDA’s 510(k) database.