GLASSMAN SILICONE CATHETER— 510(k) K934895

Name: FDA 510(k) clearance K934895
Creator: U.S. Food and Drug Administration
Published: 1994-10-13

Substantially Equivalent

Axiom Medical, Inc.

FDA 510(k) clearance K934895 for GLASSMAN SILICONE CATHETER, Substantially Equivalent on 1994-10-13. Applicant: Axiom Medical, Inc.. Device class: 2.

Clearance details

Applicant: Axiom Medical, Inc.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1993-10-05
Decision date: 1994-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Dominguez, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EZL

view all

K260756 — TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)2026-09-04
K262056 — Rusch Latex Gold Foley Catheter2026-08-05
K252537 — Rusch SoftSimplastic Foley Catheters2026-01-20
K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter)2025-06-16
K241424 — InnoCare Specialty Foley Catheter2024-09-18

More clearances from Axiom Medical, Inc.

view all

K993592 — AXIOM MULTIPURPOSE WOUND DRAIN2000-05-17
K971851 — INTERPLEURAL ANESTHESIA CATHETER1998-01-22
K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR1997-03-10
K922760 — ATRAUM WOUND DRESSING--MODIFICATION1992-10-30
K905422 — PVC ROUND WOUND DRAINS1991-02-11

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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