Quiver Laparoscopic Extendable

FDA 510(k) K153472 · Itl Corporation Pty, Ltd.

Substantially Equivalent

510(k) numberK153472

Submission

Device name
Quiver Laparoscopic Extendable
Applicant
Itl Corporation Pty, Ltd.
Chelsea Heights, Vic, AU
Received
December 2, 2015
Decision date
June 23, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAM – Apparatus, Electrosurgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Specialty
General, Plastic Surgery

Other 510(k)s with product code HAM

510(k)DeviceApplicantDecision
K000079Nikopad Electrosurgical Grounding Pad, Model 4777MHAM · Special Nikomed U.S.A., Inc.02/04/2000SE
K993306Nikopad Electrosurgical Grounding Pad (*Or Sold Under Commercial Names), Model 4760…HAM · Special Paladin Medical, Inc.11/03/1999SE
K945861Bergen 710 EsuHAM · Traditional Bergen Mfg.03/01/1995SE
K913300Laparostat(Tm)HAM · Traditional Cook Ob/Gyn04/02/1992SE
K920100Gsu Handpiece AdapterHAM · Traditional Beacon Laboratories, Inc.02/03/1992SE
K911353Emc Model No. Statome 900HAM · Traditional Emc Industries06/24/1991SE
K901248Abc Handpiece AdapterHAM · Traditional Beacon Laboratories, Inc.04/03/1990SE
K881334Light Coagulator LC 250HAM · Traditional Nk-Optik GmbH11/16/1989SE
K895337Electrosurgical Coagulation Suction TubeHAM · Traditional New England Surgical Instrument Corp.09/15/1989SE
K894762B100 Disposable HandpieceHAM · Traditional Beacon Laboratories, Inc.09/15/1989SE

More from Beacon Laboratories, Inc.

510(k)DeviceDecision
K021941Samplok Luer KitJKA · Special 07/02/2002SE
K021017Leespec Disposable Vaginal SpeculumHIB · Traditional 06/19/2002SE
K000777SamplokJKA · Traditional 04/11/2000SE
K991404Platypus Av Fistula Needle Protector (Avfnp)FMI · Traditional 05/14/1999SE

Questions and answers

When was Quiver Laparoscopic Extendable cleared by the FDA?

Quiver Laparoscopic Extendable (K153472) received a 510(k) decision of Substantially Equivalent on June 23, 2016, 204 days after the submission was received.

What is the product code of K153472?

The FDA product code is HAM – Apparatus, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.