Dr. Fog

• • Terminated Z-0897-05 FDA Unclassified (pre-2012) ·initiated 15 May 2005 ·via K932449, on the same 510(k)

  An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.

• • Terminated Z-0828-03 FDA Unclassified (pre-2012) ·initiated 30 Apr 2003 ·via K932449, on the same 510(k)

  Sterility compromised - incomplete sterile package seal.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K932449 ↗

FDA Product Code

OCT

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. →