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Medical/Surgical Suction System

by Puritan Bennett Corp. 510(k)

Active United States

510(k) K851384

Overview

The Medical/Surgical Suction System is a device designed for medical and surgical applications to remove fluids, tissues, and other materials from body cavities or surgical sites. It provides controlled suction during procedures to maintain a clear field of view and facilitate efficient removal of unwanted materials.

This device is supplied as a reusable system and is intended for use in hospital settings. It is not specified as MRI compatible, and storage requirements are not detailed in the provided data. The device has received FDA 510(k) clearance with product code GCX and is classified under the General Hospital advisory committee.

AI-generated from registry data, 23 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 NumberK851384 Date8 May 1985ClearedStatusActive

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 22 Oct 2026.

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

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Questions

  • What is the Medical/Surgical Suction System used for?

    The Medical/Surgical Suction System is designed for medical and surgical applications to remove fluids, tissues, and other materials from body cavities or surgical sites. It provides controlled suction during procedures to maintain a clear field of view and facilitate efficient removal of unwanted materials.

  • Is the Medical/Surgical Suction System reusable or single-use?

    The Medical/Surgical Suction System is supplied as a reusable system intended for use in hospital settings. It is designed to be used multiple times rather than being disposed of after a single procedure.

  • What regulatory approvals does the Medical/Surgical Suction System have?

    The Medical/Surgical Suction System has received FDA 510(k) clearance with product code GCX and is classified under the General Hospital advisory committee. This indicates it has been determined substantially equivalent to existing devices in the market.

  • Is the Medical/Surgical Suction System MRI compatible?

    The provided data does not specify whether the Medical/Surgical Suction System is MRI compatible. Users should consult the manufacturer directly or refer to the product documentation for specific information about MRI compatibility.