Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250— 510(k) K243820

Name: FDA 510(k) clearance K243820
Creator: U.S. Food and Drug Administration
Published: 2025-01-31

Substantially Equivalent

Dornier Medtech America

FDA 510(k) clearance K243820 for Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250, Substantially Equivalent on 2025-01-31. Applicant: Dornier Medtech America. Device class: 2.

Clearance details

Applicant: Dornier Medtech America
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-12-12
Decision date: 2025-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FED

view all

K260410 — Single Use Ureteral Access Sheath2026-09-11
K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
K260965 — CVAC Aspiration System2026-04-13
K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)2026-04-06
K252572 — Prodeon Urethral Sheath System2025-10-07

More clearances from Dornier Medtech America

view all

K233380 — TRIDENT Mobile Fluoroscopy System2024-06-26
K180350 — Dornier Medilas H Solvo 35 Laser2018-03-07
K170122 — Delta III Lithotripter2017-06-28
K151298 — Gemini XXP-HP2015-07-30
K132672 — EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER2013-09-23

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.