510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093508Substantially Equivalent

Rigid Cannulae Curved (Rc6-Rc12), Rigid Cannulae Straight (Rs6-Rs12)

Womancare Global, Chapel Hill NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093508 is the FDA 510(k) clearance record for RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12), a class II device, cleared for Womancare Global on under FDA product code HGH (Cannula, Suction, Uterine). FDA records list one 510(k) clearance for Womancare Global. As of , FDA records show no recalls naming K093508.

Clearance record

Decision date
Received
(112 days to decision)
Product code
HGH Cannula, Suction, Uterine
Regulation
21 CFR 884.5070
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Womancare Global 300 Market St. Suite 134, Chapel Hill NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HGH

Trailing 12 months

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

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