510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221184Substantially Equivalent

ORiGO System

Bien-Air Surgery SA, Le Noirmont, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221184 is the FDA 510(k) clearance record for ORiGO System, a class II device, cleared for Bien-Air Surgery SA on under FDA product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece). FDA records list 5 510(k) clearances for Bien-Air Surgery SA, from to . As of , FDA records show no recalls naming K221184.

Clearance record

Decision date
Received
(191 days to decision)
Product code
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Regulation
21 CFR 874.4250
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Bien-Air Surgery SA Rue De L'Ouest 2b, Le Noirmont, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ERL

Trailing 12 months

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

FDA records show no clearances under product code ERL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ERL, 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