URINARY CATHETER CARE SET— 510(k) K780735

Name: FDA 510(k) clearance K780735
Creator: U.S. Food and Drug Administration
Published: 1978-06-13

Substantially Equivalent

Shield Laboratories, Inc.

FDA 510(k) clearance K780735 for URINARY CATHETER CARE SET, Substantially Equivalent on 1978-06-13. Applicant: Shield Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Shield Laboratories, Inc.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1978-05-01
Decision date: 1978-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FCM

view all

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 Shield Laboratories, Inc.

view all

K771712 — CATHETER DRESSING CHANCE SET1977-10-13

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