ZZIREN Orogastric Tube +6 more— 510(k) K242901

Name: FDA 510(k) clearance K242901
Creator: U.S. Food and Drug Administration
Published: 2025-01-10

Substantially Equivalent

Tools For Surgery, LLC

FDA 510(k) clearance K242901 for ZZIREN Orogastric Tube +6 more, Substantially Equivalent on 2025-01-10. Applicant: Tools For Surgery, LLC. Device class: 2.

Clearance details

Device name as filed: ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
Applicant: Tools For Surgery, LLC
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-23
Decision date: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Setauket, NY, US

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 Tools For Surgery, LLC

view all

K220218 — Siren SGT2022-05-18
K040109 — HEMORRHAGE OCCLUDER PIN2004-03-25
K040110 — EASY LOOP, MODEL EZL-012004-03-24

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.