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Jar, Collector for Suction Systems

by Harris-Lake, Inc.

510(k) K760333

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 NumberK760333 Date27 Oct 1976ClearedStatusActive

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  • Withdrawn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
GCX
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
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.

This device is a Jar, Collector for Suction Systems, classified under product code GCX. It functions as a container designed to collect and retain fluids aspirated from suction therapy applications in clinical settings, ensuring proper fluid management during medical procedures.

The device is supplied as a reusable component intended for use in hospital environments. It is not sterile and must be cleaned and maintained according to facility protocols. The collector is compatible with standard suction systems and is regulated under FDA 510(k) clearance (K760333), with a decision date of October 27, 1976. No additional sterility, MRI safety, or size specifications are provided in the regulatory data.

Other devices from Harris-Lake, Inc.

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.

  • Is this suction collector jar meant for single-use or can it be reused in a clinical setting?

    This device is explicitly designed as a reusable component for hospital suction systems. Since it is not sterile and requires cleaning and maintenance per facility protocols, it is intended for repeated use in clinical environments, provided proper disinfection and upkeep are followed.

  • How is this suction collector jar regulated by the FDA, and what does that mean for its use?

    The device holds an FDA 510(k) clearance (K760333), granted under the *Traditional* review pathway by the *General Hospital* advisory committee (HO) in 1976. This means it has been determined to be *substantially equivalent* to a legally marketed device already on the market, ensuring it meets FDA safety and performance standards for its intended use in suction therapy applications.

  • What kind of cleaning and maintenance does this suction collector jar require, and why?

    Since this jar is not sterile and is reusable, it must be cleaned and maintained according to facility-specific protocols to prevent contamination and ensure proper function. The manufacturer does not specify cleaning methods, so hospitals must follow their own infection control and device maintenance guidelines to sustain usability and safety in clinical suction systems.

  • Can this suction collector jar be used with any standard suction system, or are there compatibility restrictions?

    The device is designed for compatibility with standard suction systems in clinical settings, as stated in its description. However, since no additional technical specifications (e.g., size, connection type) are provided, facilities should verify physical and functional fit with their existing equipment before use.