Wingeater V2

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K111948 ↗

FDA Product Code

FIE

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Neoshield

  Class II

  FDA 510(k) K172499 Active Cleared 1 Jun 2018

• Sysloc Mini V3

  Class II

  FDA 510(k) K110157 Active Cleared 11 Feb 2011

• Jms Sysloc Mini Avf and Apheresis Needle Sets

  Class II

  FDA 510(k) K070234 Active Cleared 22 May 2007

• Jms Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300

  Class II

  FDA 510(k) K093637 Active Cleared 9 Feb 2010

• JMS Harmony A.V. Fistula Needle Set

  Class II

  FDA 510(k) K151017 Active Cleared 13 May 2015

• Jms Extension Set with Planecta, Planecta (Stand Alone Unit), Planecta Lock & Planecta Adaptor

  Class II

  FDA 510(k) K023668 Active Cleared 1 Jul 2003

See all devices from JMS North America Corporation →

• What is the Wingeater V2 used for?

  The Wingeater V2 is a fistula needle intended for use in medical procedures within the gastroenterology and urology specialties.

• What is the regulatory status of this device?

  The Wingeater V2 is a class 2 medical device that has received FDA 510(k) clearance under submission number K111948, confirming it is substantially equivalent to legally marketed predicate devices.

• Which medical specialties utilize the Wingeater V2?

  This device is specifically associated with the gastroenterology and urology medical specialties, as indicated by its classification under regulation number 876.5540 and its review by the GU advisory committee.