510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935820Substantially Equivalent

Kolster Methods

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

K935820 is the FDA 510(k) clearance record for KOLSTER METHODS, a class II device, cleared for Kolster Methods on under FDA product code HGH (Cannula, Suction, Uterine). FDA records list 3 510(k) clearances for Kolster Methods, from to . As of , FDA records show no recalls naming K935820.

Clearance record

Decision date
Received
(228 days to decision)
Product code
HGH Cannula, Suction, Uterine
Regulation
21 CFR 884.5070
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Kolster Methods 2550 W. Rowland Ave., Anaheim CA
510(k) summary
Statement
Third party review
No

Clearances, product code HGH

Trailing 12 months

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

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