Folhy Catheter

FDA 510(k) K771860 · Polysil, Inc.

Substantially Equivalent

510(k) numberK771860

Submission

Device name
Folhy Catheter
Applicant
Polysil, Inc.
Mchenry, IL, US
Received
September 30, 1977
Decision date
October 18, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Questions and answers

When was Folhy Catheter cleared by the FDA?

Folhy Catheter (K771860) received a 510(k) decision of Substantially Equivalent on October 18, 1977, 18 days after the submission was received.

What is the product code of K771860?

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