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510(k) K201776

Foley Balloon Catheter for Urology by Apollon Co., Ltd. — Product Code EZL

K201776 is an FDA 510(k) premarket notification submitted by Apollon Co., Ltd. for the device "Foley Balloon Catheter for Urology". The FDA issued a decision of Substantially Equivalent on December 30, 2020. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2020
Date Received
June 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K240057 — TraumaGuard Intra-abdominal Pressure Sensing System (April 17, 2024)
  • K233411 — Folysil Silicone Catheter (April 15, 2024)
  • K233013 — 2-Way 100% Silicone Cleartract Catheter (January 23, 2024)
  • K212077 — Teleflex Rusch SoftSimplastic Foley Catheters (July 27, 2023)
  • K231101 — Flume Catheter (June 29, 2023)
  • K221020 — Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accu (January 13, 2023)

FDA data resources