STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW— 510(k) K023539

Name: FDA 510(k) clearance K023539
Creator: U.S. Food and Drug Administration
Published: 2002-12-17

Substantially Equivalent

Valumed

FDA 510(k) clearance K023539 for STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW, Substantially Equivalent on 2002-12-17. Applicant: Valumed. Device class: 2.

Clearance details

Applicant: Valumed
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2002-10-22
Decision date: 2002-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niceville, FL, US

Download summary PDF View on FDA.gov ↗

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K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP092003-02-04

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.