Flexi-Seal Signal Fecal Management System— 510(k) K150350

Name: FDA 510(k) clearance K150350
Creator: U.S. Food and Drug Administration
Published: 2015-07-21

Substantially Equivalent

Convatec, Ltd.

FDA 510(k) clearance K150350 for Flexi-Seal Signal Fecal Management System, Substantially Equivalent on 2015-07-21. Applicant: Convatec, Ltd.. Device class: 2.

Clearance details

Applicant: Convatec, Ltd.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2015-02-11
Decision date: 2015-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deeside, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNT

view all

K261890 — 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®2026-08-14
K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more2026-07-10
K250389 — XNY Disposable Gastric Calibration Tube2025-04-10
K243228 — Flexi-Seal AIR (with ENFit Connector)2025-03-28
K242336 — hygh-tec Drainage II2025-01-17

More clearances from Convatec, Ltd.

view all

K140953 — GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER2014-08-01
K973688 — DUODERM CONTROL GEL FORMULA BORDER DRESSING1997-12-23
K973689 — DUODERM HYDROACTIVE DRESSING1997-12-23

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.