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Ambu Universal Suction Pump

by Narco Air-Shields

510(k) K792592

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 NumberK792592 Date11 Jan 1980ClearedStatusActive

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  • Withdrawn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
JCX
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Ambu Universal Suction Pump is an apparatus for suction, ward use, portable, and ac-powered. It is classified as a Class II device with special controls.

The device is supplied by Narco Air-Shields and has a product code of JCX. It is intended for general and plastic surgery use, and has a regulation number of 878.4780. The device was cleared by the FDA on January 11, 1980, with a substantially equivalent decision.

Other devices from Narco Air-Shields

See all devices from Narco Air-Shields →

Questions

AI-generated answers, 25 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 Ambu Universal Suction Pump used for?

    The Ambu Universal Suction Pump is intended for general and plastic surgery use, providing a portable and ac-powered solution for suction in ward settings.

  • Is the Ambu Universal Suction Pump cleared by the FDA?

    Yes, the Ambu Universal Suction Pump was cleared by the FDA on January 11, 1980, with a substantially equivalent decision, and is classified as a Class II device with special controls.

  • What is the product code for the Ambu Universal Suction Pump?

    The product code for the Ambu Universal Suction Pump is JCX, and it has a regulation number of 878.4780.