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Colab Cocath Implanted Catheter and Depot

by Colab Intl., Inc.

510(k) K896197

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK896197 Date11 Jul 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Colab Cocath(Tm) Implanted Catheter and Depot
510(k) Number
FDA Product Code
KXK
Device Class
Class II
Regulation
21 CFR Part 892.5730
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Colab Cocath Implanted Catheter and Depot is a brachytherapy device designed for the implantation of radionuclides. It serves as a catheter-based system for delivering localized radiation therapy, typically used in radiology procedures for targeted treatment of specific tissues or tumors.

This device is supplied as a single-use, sterile implant intended for use in controlled clinical settings. It is classified under FDA regulation 892.5730 and holds a 510(k) clearance (K896197) as substantially equivalent to a predicate device. The product code KXK identifies it within the FDA’s classification system, and its design adheres to radiology-specific standards for brachytherapy applications.

Questions

AI-generated answers, 19 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 Colab Cocath Implanted Catheter and Depot used for?

    The Colab Cocath is a brachytherapy device designed for implantation of radionuclides to deliver localized radiation therapy, typically used in radiology procedures for targeted treatment of specific tissues or tumors.

  • Is the Colab Cocath device reusable or single-use?

    The Colab Cocath is supplied as a single-use, sterile implant intended for use in controlled clinical settings and should not be reused for patient safety reasons.

  • What regulatory classification does the Colab Cocath hold?

    The device is classified under FDA regulation 892.5730 with product code KXK and holds a 510(k) clearance (K896197) as substantially equivalent to a predicate device.

  • How is the Colab Cocath supplied to healthcare facilities?

    The device is supplied as a sterile implant in packaging suitable for clinical use, though specific packaging details are not provided in the available information.