OXYCEL

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Agent, absorbable hemostatic, non-collagen based

PMA Number

N5798 ↗

FDA Product Code

LMG

Device Class

Class III

Regulation

21 CFR Part 878.4490

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

PMA Supplement

S004

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is OXYCEL used for?

  OXYCEL is an absorbable hemostatic agent that is non-collagen based, indicated for use in general and plastic surgery to control bleeding, as specified in its generic name and advisory committee description.

• Is OXYCEL a single-use or reusable device?

  OXYCEL is supplied as a sterile, single-use device, consistent with its classification as an absorbable hemostatic agent intended for immediate application and absorption in surgical settings.

• What regulatory authorization does OXYCEL have?

  OXYCEL received FDA Premarket Approval (PMA) under number N5798, with the decision made on December 17, 1982, following submission on June 29, 1982.