Enteron Abdominal Paracentesis Tray

• • Ongoing Z-2386-2026 FDA Class I ·initiated 21 Apr 2026

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

• • Terminated Z-1965-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1297-2018 FDA Class II ·initiated 24 Oct 2017

  Product packaging may not be completely sealed.

510(k) Number

K874063 ↗

FDA Product Code

KDD

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESD Substantially Equivalent — Deferred

• Oval Cup Biopsy Forcep

  Class II

  FDA 510(k) K911155 Active Cleared 7 Aug 1991

• Cleaning Brush

  Class I

  FDA 510(k) K874239 Active Cleared 29 Dec 1987

• Guide Wire

  Class I

  FDA 510(k) K874164 Active Cleared 7 Dec 1987

• Sheath, Endoscope

  Class II

  FDA 510(k) K862059 Active Cleared 4 Nov 1986

• Polypectomy Snare

  Class II

  FDA 510(k) K862060 Active Cleared 27 Jun 1986

• Endoscopic Retrograde Cholangiopancreatography

  Class II

  FDA 510(k) K860990 Active Cleared 13 May 1986

See all devices from Endovations →