510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023227Substantially Equivalent

Usg 2000Sa

Ultraguide, Ltd., Hasbrouck Heights NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023227 is the FDA 510(k) clearance record for USG 2000SA, a class II device, cleared for Ultraguide , Ltd. on under FDA product code HHJ (Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic). FDA records list 6 510(k) clearances for Ultraguide , Ltd., from to . As of , FDA records show no recalls naming K023227.

Clearance record

Decision date
Received
(25 days to decision)
Product code
HHJ Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
Regulation
21 CFR 884.2225
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ultraguide , Ltd. 377 Rte. 17 S., Hasbrouck Heights NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HHJ

Trailing 12 months

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

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