510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K921738Substantially Equivalent

Sono-Vu Us(tm), Modification

E-Z-EM, Inc, Glens Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921738 is the FDA 510(k) clearance record for SONO-VU US(TM), MODIFICATION, a class I device, cleared for E-Z-Em, Inc. on under FDA product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)). FDA records list 56 510(k) clearances for E-Z-Em, Inc., from to . As of , FDA records show no recalls naming K921738.

Clearance record

Decision date
Received
(89 days to decision)
Product code
HIO Sampler, Amniotic Fluid (Amniocentesis Tray)
Regulation
21 CFR 884.1550
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
E-Z-Em, Inc. P.O. Box 993, Glens Falls NY
510(k) summary
Statement
Third party review
No

Clearances, product code HIO

Trailing 12 months

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

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