Vectec Disposable Pneumoperitoneum Needle

FDA 510(k) K121370 · Vectec

Substantially Equivalent

510(k) numberK121370

Submission

Device name
Vectec Disposable Pneumoperitoneum Needle
Applicant
Vectec
Fairfax, VA, US
Received
May 7, 2012
Decision date
August 2, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FHO – Pneumoperitoneum Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

For establishment of a pneumoperitoneum in abdomen.

Other 510(k)s with product code FHO

510(k)DeviceApplicantDecision
K172120Veress NeedleFHO · Traditional Wickimed (Huizhou) Medical Equipment…09/14/2017SE
K010779Modification To:Laparoscopic/Endoscopic InstrumentFHO · Special Gibbons Surgical Corp.04/10/2001SE
K970788Pneumo-Matic Insufflation NeedleFHO · Traditional Apple Medical Corp.03/27/1997SE
K960574Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter…FHO · Traditional Sherwood Medical Co.08/05/1996SE
K951894Access Expansion SystemFHO · Traditional Micro-Medical Devices, Inc.06/15/1995SESK
K943624Elmed Pneumoperitoneum NeedlesFHO · Traditional Henke-Sass, Wolf GmbH08/10/1994SE
K942484Verres NeedleFHO · Traditional Linvatec Corp.06/24/1994SE
K930474Needle, Pneumoperitoneum, Spring LoadedFHO · Traditional Ranfac, Corp.07/23/1993SE
K915725Clarus Models 1230 and 1231 Laparo-NeedleFHO · Traditional Clarus Medical Systems, Inc.11/16/1992SE
K914426Entree NeedleFHO · Traditional Core Dynamics, Inc.11/27/1991SE

More from Core Dynamics, Inc.

510(k)DeviceDecision
K103707Vectec Disposable Monopolar Connector CableGEI · Traditional 02/04/2011SE
K071976Vectec Disposable Trocars and Laparoscopic AccessoriesGEI · Traditional 09/06/2007SE

Questions and answers

When was Vectec Disposable Pneumoperitoneum Needle cleared by the FDA?

Vectec Disposable Pneumoperitoneum Needle (K121370) received a 510(k) decision of Substantially Equivalent on August 2, 2013, 452 days after the submission was received.

What is the product code of K121370?

The FDA product code is FHO – Pneumoperitoneum Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1500.