510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K881036Substantially Equivalent

Hemo Suc Number Hs100-Hs205

Instrumental Medico Croquevielle S.A., Santiago, Chile, CL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881036 is the FDA 510(k) clearance record for HEMO SUC NUMBER HS100-HS205, a class I device, cleared for Instrumental Medico Croquevielle S.A. on under FDA product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered). FDA records list one 510(k) clearance for Instrumental Medico Croquevielle S.A. As of , FDA records show no recalls naming K881036.

Clearance record

Decision date
Received
(102 days to decision)
Product code
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Regulation
21 CFR 878.4680
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Instrumental Medico Croquevielle S.A. For Embassador, Santiago, Chile, CL
Third party review
No

Clearances, product code GCY

Trailing 12 months

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

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