510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895762Substantially Equivalent

Canula Suction for Surgical General and Plastic

Kolster Methods, Fullerton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895762 is the FDA 510(k) clearance record for CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC, a class I device, cleared for Kolster Methods on under FDA product code GEA (Cannula, Surgical, General & Plastic Surgery). FDA records list 3 510(k) clearances for Kolster Methods, from to . As of , FDA records show no recalls naming K895762.

Clearance record

Decision date
Received
(22 days to decision)
Product code
GEA Cannula, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Kolster Methods 1895 W. Commonwealth Ave., Fullerton CA
Third party review
No

Clearances, product code GEA

Trailing 12 months

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

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