Norfolk Omega Port-LP Subcutaneous Implanted

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

Full name

Norfolk Omega Port-LP Subcutaneously Implanted

510(k) Number

K942784 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Norfolk Medical NorPort

  Class II

  FDA 510(k) K871209 Active Cleared 24 Jun 1987

• Norfolk Medical Peritoneal-Access Port

  Class III

  FDA 510(k) K854593 Active Cleared 4 Feb 1986

• Vascular Access Port Changes in Mater LJT

  Class II

  FDA 510(k) K840788 Active Cleared 24 Apr 1984

• TidalPort-AP Implantable Apheresis Vascular Access Port

  Class II

  FDA 510(k) K192291 Active Cleared 20 Aug 2020

• Vascular-Access-Port LJT

  Class II

  FDA 510(k) K830000 Active Cleared 1 Mar 1983

• Norfolk Norport, Subcut. Implanted Drug Del. Depot

  Class II

  FDA 510(k) K870187 Active Cleared 7 May 1987

See all devices from Norfolk Medical Products, Inc. →

• Is the Norfolk Omega Port-LP designed for reuse or is it intended for single-use only?

  The Norfolk Omega Port-LP is explicitly designed for single-use implantation under sterile conditions. It is supplied as a pre-assembled, sterile system, which aligns with best practices for minimizing infection risk in long-term intravenous access.

• What types of clinical settings is this device primarily used in, and what are its common applications?

  The Norfolk Omega Port-LP is primarily used in general hospital settings for patients requiring chronic intravenous therapies. Common applications include administration of chemotherapy, parenteral nutrition, and antibiotics, as it provides reliable long-term access while reducing patient discomfort and infection risk.

• How is the device supplied, and what should clinicians ensure before implantation?

  The Norfolk Omega Port-LP is supplied as a sterile, pre-assembled system, meaning it is ready for immediate use without additional sterilization. Clinicians should ensure the system remains sterile until implantation and follow aseptic techniques to prevent contamination during the procedure.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Norfolk Omega Port-LP received FDA 510(k) clearance (K942784) under a traditional review pathway, with a decision of substantially equivalent (SESE) to a predicate device. It is classified as a Class II medical device (880.5965) under the Port & Catheter, Implanted, Subcutaneous, Intravascular category.