Cherry Sponge

• • Completed Z-2221-2024 FDA Class II ·initiated 3 Jun 2024

  The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.

510(k) Number

K913500 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• O.R. Concepts' Irrigating Kittner

  Class II

  FDA 510(k) K923818 Active Cleared 7 Apr 1993

• Flowgun Electrocautery Probes

  Class II

  FDA 510(k) K941337 Active Cleared 17 Aug 1994

• Flowgun Electrocautery Probe Handle

  Class II

  FDA 510(k) K935970 Active Cleared 16 May 1994

• O.R. Concepts Electrosurgical Probes

  Class II

  FDA 510(k) K923199 Active Cleared 20 Nov 1992

• Instrument Organizer

  Class I

  FDA 510(k) K914960 Active Cleared 28 Feb 1992

• Eye Barrier

  Class I

  FDA 510(k) K863182 Active Cleared 3 Sep 1986

See all devices from O.R. Concepts, Inc. →