Company · US

Gynetech Pty. , Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2015. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
LKF	Cannula, Manipulator/Injector, Uterine	2
HEW	Culdoscope (And Accessories)	1
HHT	Spatula, Cervical, Cytological	1
HIF	Insufflator, Laparoscopic	1

Decided	510(k)	Device and applicant	Code
Aug 19, 2015	K150519	ManipulatOR PRO, ManipulatOR Gynetech Pty. , Ltd., AU	LKF
Dec 19, 2014	K142700	InsufflatOR Needle Gynetech Pty. , Ltd., AU	HIF
Dec 17, 2014	K142164	MANIPULATOR; MANIPULATOR PRO Gynetech Pty. , Ltd.	LKF
Sep 2, 2005	K051594	MCCARTNEY ACCESS TUBE Gynetech Pty. , Ltd.	HEW
Dec 22, 1995	K954562	GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT Gynetech, Inc.	HHT

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.