STERILE CATHERIZATION PROCEDURE TRAYS— 510(k) K830359
Substantially EquivalentWelcon, Inc.
FDA 510(k) clearance K830359 for STERILE CATHERIZATION PROCEDURE TRAYS, Substantially Equivalent on 1983-03-17. Applicant: Welcon, Inc.. Device class: 2.
Clearance details
- Applicant
- Welcon, Inc.
- Product code
- Code KOD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KOD
view allMore clearances from Welcon, Inc.
view all- K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
- K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
- K971764 — WELCON HUE-VU URINARY DRAINAGE BAG
- K912869 — WOMEN AND INFANT'S DELIVERY PACK
- K904158 — ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
Adverse events under product code KOD
product code KOD- Death
- 5
- Injury
- 1,129
- Malfunction
- 7,019
- Total
- 8,153
Source: openFDA MAUDE database, through . 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.