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510(k) K923818

O.R. CONCEPTS' IRRIGATING KITTNER by O.R. Concepts, Inc. — Product Code FGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1993
Date Received
July 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carrier, Sponge, Endoscopic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K926242 — ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE (October 15, 1993)
  • K922197 — INSUFFLATOR TUBING KIT (September 24, 1993)
  • K922244 — INSUFFLATOR TUBING/FILTER KIT (September 24, 1993)
  • K932449 — DR. FOG (August 11, 1993)
  • K925147 — ORC 10.0MM SUCTION PROBE (June 25, 1993)
  • K925024 — ORC TAPPERED IRRIGATING PROBE (May 21, 1993)

Other clearances for product code FGS

  • K933604 — QB II BLUNT DISSECTOR (September 23, 1993)
  • K931854 — ENDOSCOPIC BLUNT DISSECTING INSTRUMENT (August 10, 1993)
  • K822194 — ENDOSCOPIC SPONGE CARRIER (August 27, 1982)