510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883283Substantially Equivalent

Disposable Amniotome

Galenica Enterprises, Inc., Quebec Canada J7e 4h7, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883283 is the FDA 510(k) clearance record for DISPOSABLE AMNIOTOME, a class II device, cleared for Galenica Enterprises, Inc. on under FDA product code HGG (Controller, Abortion Unit, Vacuum). FDA records list 5 510(k) clearances for Galenica Enterprises, Inc., from to . As of , FDA records show no recalls naming K883283.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HGG Controller, Abortion Unit, Vacuum
Regulation
21 CFR 884.5070
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Galenica Enterprises, Inc. C.p. 13, Quebec Canada J7e 4h7, CA
Third party review
No

Clearances, product code HGG

Trailing 12 months

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

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