MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM— 510(k) K030315

Name: FDA 510(k) clearance K030315
Creator: U.S. Food and Drug Administration
Published: 2003-02-27

Substantially Equivalent

Ultroid, LLC

FDA 510(k) clearance K030315 for MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM, Substantially Equivalent on 2003-02-27. Applicant: Ultroid, LLC. Device class: 2.

Clearance details

Applicant: Ultroid, LLC
Product code: Code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2003-01-30
Decision date: 2003-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Carson City, NV, US

Download summary PDF View on FDA.gov ↗

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K260962 — Sphincterotome2026-05-21
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K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)2025-11-25
K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more2025-10-17

More clearances from Ultroid, LLC

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K023706 — ULTROID HEMORRHOID MANAGEMENT SYSTEM2003-01-14

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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 →

Recalls naming K030315

K-number listed on FDA's recall record

Z-0782-2017 — Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile ProbesClass II·Terminated·Ultroid Technologies, Inc.·20161019
Z-0783-2017 — Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable ProbesClass II·Terminated·Ultroid Technologies, Inc.·20161019
Z-0784-2017 — Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.Class II·Terminated·Ultroid Technologies, Inc.·20161019
Z-0785-2017 — Ultroid Sterile Disposable Probes sold individuallyClass II·Terminated·Ultroid Technologies, Inc.·20161019

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030315.

Data sourced from openFDA. This site is unofficial and independent of the FDA.