510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133144Substantially Equivalent

Sonosure Sonohysterography & Endometrial Sampling Device

Crossbay Medical, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133144 is the FDA 510(k) clearance record for SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE, a class II device, cleared for Crossbay Medical, Inc. on under FDA product code PGK (Cannula, Injector, Uterine, Endometrial Biopsy). FDA's definition for product code PGK reads: "to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy". FDA records list 6 510(k) clearances for Crossbay Medical, Inc., from to . As of , FDA records show no recalls naming K133144.

Clearance record

Decision date
Received
(153 days to decision)
Product code
PGK Cannula, Injector, Uterine, Endometrial Biopsy
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Crossbay Medical, Inc. 17141 Murphy Ave., Suite 5c, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGK

Trailing 12 months

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

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