Olympus Sd Series Snares

• 4 recalls, same reason

  • Terminated Z-0990-2021 FDA Class II ·initiated 4 Jan 2021 ·on shared 510(k) K955650
  • Terminated Z-0988-2021 FDA Class II ·initiated 4 Jan 2021 ·on shared 510(k) K955650
  • Terminated Z-0987-2021 FDA Class II ·initiated 4 Jan 2021 ·on shared 510(k) K955650
  • Terminated Z-0989-2021 FDA Class II ·initiated 4 Jan 2021 ·on shared 510(k) K955650

  Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

• • Terminated Z-2236-2010 FDA Unclassified (pre-2012) ·initiated 3 May 2010

  An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K955650 ↗

FDA Product Code

FDI

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 3D Surgical Endoscopy System for General Surgery

  Class II

  FDA 510(k) K943307 Active Cleared 20 Dec 1995

• Olympus Fg-45/46-1 Grasping Forceps

  Class II

  FDA 510(k) K955049 Active Cleared 15 Dec 1995

• Olympus Unsaturated Iron Binding Capacity Reagent

  Class I

  FDA 510(k) K955139 Active Cleared 12 Feb 1996

• Olympus Fb Series Biopsy Forceps

  Class II

  FDA 510(k) K962555 Active Cleared 30 Jul 1996

• Olympus Fd-5 Hot Biopsy Forceps

  Class II

  FDA 510(k) K951445 Active Cleared 3 May 1995

• Olympus Biopsy Forceps Model Fb-44

  Class II

  FDA 510(k) K950786 Active Cleared 6 Mar 1995

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