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Quadroject

by Ellis Pharmaceutical Consulting, Inc.

510(k) K884233

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 NumberK884233 Date30 Jan 1989ClearedStatusActive

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  • Withdrawn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)

Full name
Quadroject(Tm)
510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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 Quadroject is a device classified under product code FMF, which corresponds to a general hospital device type as indicated by the advisory committee description. It was determined to be substantially equivalent through a traditional 510(k) clearance process.

The device was manufactured by Ellis Pharmaceutical Consulting, Inc., received on October 7, 1988, and cleared on January 30, 1989, under k-number K884233. It is authorized for distribution in the United States and is associated with the General Hospital advisory committee (HO).

Other devices from Ellis Pharmaceutical Consulting, Inc.

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 Quadroject(TM) device used for?

    The Quadroject(TM) is classified under product code FMF as a general hospital device, indicating it is intended for use in general hospital settings based on the advisory committee description, though specific clinical indications are not detailed in the authorization data.

  • How was the Quadroject(TM) authorized for market distribution?

    The Quadroject(TM) received market authorization through a traditional 510(k) clearance process, demonstrating substantial equivalence to a predicate device, and was cleared on January 30, 1989, under k-number K884233 by the FDA.

  • Who manufactures the Quadroject(TM) and where is it authorized for distribution?

    The Quadroject(TM) is manufactured by Ellis Pharmaceutical Consulting, Inc., located in Princeton, NJ, and is authorized for distribution in the United States, as indicated by the U.S. country code and FDA clearance.