510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K083594Substantially Equivalent

Ez Hsg Catheter.foamseal Catheter

Obg Products, Vienna VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083594 is the FDA 510(k) clearance record for EZ HSG CATHETER.FOAMSEAL CATHETER, a class II device, cleared for Obg Products on under FDA product code LKF (Cannula, Manipulator/Injector, Uterine). FDA records list one 510(k) clearance for Obg Products. As of , FDA records show no recalls naming K083594.

Clearance record

Decision date
Received
(228 days to decision)
Product code
LKF Cannula, Manipulator/Injector, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Obg Products 8292c Old Ct.house Rd., Vienna VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKF

Trailing 12 months
2 clearances under product code LKF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LKF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260