510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905812Substantially Equivalent

Intrauterine Catheter Set

Epcom Medical Systems, Inc., Livermore CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905812 is the FDA 510(k) clearance record for INTRAUTERINE CATHETER SET, a class II device, cleared for Epcom Medical Systems, Inc. on under FDA product code HGS (Catheter, Intrauterine And Introducer). FDA records list 13 510(k) clearances for Epcom Medical Systems, Inc., from to . As of , FDA records show no recalls naming K905812.

Clearance record

Decision date
Received
(34 days to decision)
Product code
HGS Catheter, Intrauterine And Introducer
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Epcom Medical Systems, Inc. 302 Lindbergh Ave., Livermore CA
Third party review
No

Clearances, product code HGS

Trailing 12 months

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

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