Hang&Go PAC— 510(k) K161613

Name: FDA 510(k) clearance K161613
Creator: U.S. Food and Drug Administration
Published: 2016-12-28

Substantially Equivalent

Rand S.R.L.

FDA 510(k) clearance K161613 for Hang&Go PAC, Substantially Equivalent on 2016-12-28. Applicant: Rand S.R.L.. Device class: 2.

Clearance details

Applicant: Rand S.R.L.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2016-06-10
Decision date: 2016-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medolla, IT

Download summary PDF View on FDA.gov ↗

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K120026 — PERFORMER HT/ HANG&GO HT BASIC2012-05-08
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Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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 K161613

K-number listed on FDA's recall record

Z-2048-2021 — Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120Class II·Terminated·RanD S.r.l.·20210430

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161613.

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