SUCTION CATHETER TRAYS— 510(k) K833059

Name: FDA 510(k) clearance K833059
Creator: U.S. Food and Drug Administration
Published: 1983-12-12

Substantially Equivalent

Intermed, Inc.

FDA 510(k) clearance K833059 for SUCTION CATHETER TRAYS, Substantially Equivalent on 1983-12-12. Applicant: Intermed, Inc.. Device class: 1.

Clearance details

Applicant: Intermed, Inc.
Product code: Code GBZ
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1983-09-08
Decision date: 1983-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE1993-07-13

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K900857 — NON STERILE PARENTERAL SUPPLY KIT1990-05-22
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K833126 — DRESSING CHANGE TRAYS1984-01-27
K833573 — CENTRAL VEIN CATH. TRAY CC-20-14201984-01-11
K833574 — PERCUTANEOUS SHEATH INTRODUCER TRAYS1984-01-11

Adverse events under product code GBZ

product code GBZ

Death: 2
Total: 2

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.