Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1531050

FEI Number

3002755653

Entity Name

NORMAN NOBLE, INC.

City/State/Country

Highland Heights, OH, US

Establishment Address

5500 Avion Park Drive, Highland Heights, OH 44143, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Norman Noble, Inc. (Owner Number: 10042188)

Owner / Operator Contact Address

5507 Avion Park Drive, Highland Heights, OH 44143, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PALMAZ GENESIS Transhepatic Biliary Stent PALMAZ Transhepatic Biliary Stent BIPAL Biopsy Forceps Palmaz Mullins PALMAZ GENESIS Transhepatic Biliary Stent PALMAZ Balloon-Expandable Stent Compression FT Screws PALMAZ GENESIS Transhepatic Biliary Stent Mesh Bone plate PALMAZ XL Transhepatic Biliary Stent Vitality Spinal Fixation System Vitality System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2012-10-30
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2012-10-30
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	Class 2	870.4075	2025-05-08
QWC	Pulmonary Stent	Unknown	Class 3	N/A	2026-04-17
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2012-10-30
NIN	Stent, Renal	Unknown	Class 3	N/A	2012-10-30
NIO	Stent, Iliac	Unknown	Class 3	N/A	2012-10-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-11-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2012-10-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-06-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2012-10-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-04-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Norman Noble, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1531050. Last updated year: 2026. Please use registration number 1531050 when referencing this establishment in official correspondence.