WELCON HUE-VU URINARY DRAINAGE BAG— 510(k) K971764
Substantially EquivalentWelcon, Inc.
FDA 510(k) clearance K971764 for WELCON HUE-VU URINARY DRAINAGE BAG, Substantially Equivalent on 1997-07-29. Applicant: Welcon, Inc.. Device class: 2.
Clearance details
- Applicant
- Welcon, Inc.
- Product code
- Code KNX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Providence, RI, US
Recent devices under product code KNX
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
- K912869 — WOMEN AND INFANT'S DELIVERY PACK
- K904158 — ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
- K894397 — WELCON LIGHT HANDLE
Adverse events under product code KNX
product code KNX- Malfunction
- 1,064
- Total
- 1,064
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.