CATHETERIZATION PROCEDURE TRAY— 510(k) K780123

Substantially Equivalent

Walpak Co.

FDA 510(k) clearance K780123 for CATHETERIZATION PROCEDURE TRAY, Substantially Equivalent on 1978-02-21. Applicant: Walpak Co.. Device class: 2.

Clearance details

Applicant: Walpak Co.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1978-01-24
Decision date: 1978-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FCM

K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit2026-05-29
K250891 — Cure Catheter Insertion Kit (K1) +12 more2025-06-06
K223821 — Self-Cath Closed System2023-08-02
K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM2008-10-23
K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM2007-06-01

More clearances from Walpak Co.

K803200 — IRRIGATION SET W/BULB SYRINGE1981-01-21
K803204 — IRRIGATION PISTON1981-01-21
K803198 — IRRIGATION SET W/PISTON SYRINGE1981-01-15
K803199 — SUTURE REMOVAL KIT1981-01-15
K803201 — LEMON GLYCERINE SWABS1980-12-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.