PREVANTICS DEVICE SWAB— 510(k) K132380

Name: FDA 510(k) clearance K132380
Creator: U.S. Food and Drug Administration
Published: 2014-08-27

Substantially Equivalent

Professional Disposables International, Inc.

FDA 510(k) clearance K132380 for PREVANTICS DEVICE SWAB, Substantially Equivalent on 2014-08-27. Applicant: Professional Disposables International, Inc.. Device class: Unclassified.

Clearance details

Applicant: Professional Disposables International, Inc.
Product code: Code LKB
Device class: Unclassified
Advisory panel: Unknown
Date received: 2013-07-31
Decision date: 2014-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKB

view all

K121655 — BD ALCOHOL SWAB2013-03-20
K112791 — SITESCRUB IPA DEVICE2012-02-24
K912161 — I.V. STARR KIT1991-10-08
K912731 — STERI-SWAB1991-10-02
K910735 — HEXIDIS ALCOHOL SWAB1991-04-02

Adverse events under product code LKB

product code LKB

Other: 2
Total: 2

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.