Well Lead Silicone and Latex Foley Catheters

FDA 510(k) K082815 · Well Lead Medical Instruments

Substantially Equivalent

510(k) numberK082815

Submission

Device name
Well Lead Silicone and Latex Foley Catheters
Applicant
Well Lead Medical Instruments
Guangzhou City, CN
Received
September 25, 2008
Decision date
October 8, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
EZL – Catheter, Retention Type, Balloon
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

Other 510(k)s with product code EZL

510(k)DeviceApplicantDecision
K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional Sentinel Medical Technologies,09/04/2026SE
K262056Rusch Latex Gold Foley CatheterEZL · Traditional Teleflex Medical Sdn. Bhd.08/05/2026SE
K252537Rusch SoftSimplastic Foley CathetersEZL · Traditional Teleflex Medical Sdn. Bhd.01/20/2026SE
K243011Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional Guangdong Ecan Medical Co., Ltd.06/16/2025SE
K241424InnoCare Specialty Foley CatheterEZL · Traditional Innocare Urologics, LLC09/18/2024SE
K232469Rüsch Latex Gold Foley CatheterEZL · Traditional Teleflexmedical, Inc.08/01/2024SE
K240057TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional Sentinel Medical Technologies, LLC04/17/2024SE
K233411Folysil Silicone CatheterEZL · Traditional Coloplast Corp.04/15/2024SE
K2330132-Way 100% Silicone Cleartract CatheterEZL · Traditional Silq Technologies Corporation01/23/2024SE
K212077Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional Teleflexmedical, Inc.07/27/2023SE

More from Teleflexmedical, Inc.

510(k)DeviceDecision
K073383Well Lead Reinforced Endotracheal TubeBTR · Traditional 07/10/2008SE
K042683Well Lead Endotracheal TubeBTR · Traditional 02/18/2005SE
K042684Well Lead Tracheostomy TubeBTO · Traditional 02/17/2005SE

Questions and answers

When was Well Lead Silicone and Latex Foley Catheters cleared by the FDA?

Well Lead Silicone and Latex Foley Catheters (K082815) received a 510(k) decision of Substantially Equivalent on October 8, 2008, 13 days after the submission was received.

What is the product code of K082815?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.