510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945179Substantially Equivalent

Bottle Collection Set

Medgyn Products, Inc., Lombard IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945179 is the FDA 510(k) clearance record for BOTTLE COLLECTION SET, a class II device, cleared for Medgyn Products, Inc. on under FDA product code HGF (Source, Abortion Unit, Vacuum). FDA records list 5 510(k) clearances for Medgyn Products, Inc., from to . As of , FDA records show no recalls naming K945179.

Clearance record

Decision date
Received
(94 days to decision)
Product code
HGF Source, Abortion Unit, Vacuum
Regulation
21 CFR 884.5070
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medgyn Products, Inc. 328 N. Eisenhower Ln., Lombard IL
510(k) summary
Statement
Third party review
No

Clearances, product code HGF

Trailing 12 months

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

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