510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161613Substantially Equivalent

Hang&Go PAC

RAND S.p.A., Medolla, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161613 is the FDA 510(k) clearance record for Hang&Go PAC, a class II device, cleared for Rand S.R.L. on under FDA product code LGZ (Warmer, Thermal, Infusion Fluid). FDA records list one 510(k) clearance for Rand S.R.L. As of , FDA records show one recall naming K161613.

Clearance record

Decision date
Received
(201 days to decision)
Product code
LGZ Warmer, Thermal, Infusion Fluid
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Rand S.R.L. Via Statale 12, 62, Medolla, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LGZ

Trailing 12 months
3 clearances under product code LGZ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LGZ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260