510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163455Substantially Equivalent

SurgiCube

Surgicube International B.V., Vierpolders, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163455 is the FDA 510(k) clearance record for SurgiCube, a class II device, cleared for Surgicube International B.V. on under FDA product code ORC (Air Filter Portable Apparatus). FDA's definition for product code ORC reads: "The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures". FDA records list one 510(k) clearance for Surgicube International B.V. As of , FDA records show no recalls naming K163455.

Clearance record

Decision date
Received
(293 days to decision)
Product code
ORC Air Filter Portable Apparatus
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Surgicube International B.V. Seggelant-Noord 4, Vierpolders, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORC

Trailing 12 months

FDA records hold no clearances under product code ORC in the trailing twelve months.

FDA records show no clearances under product code ORC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ORC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260