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510(k) K923818

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

K923818 is an FDA 510(k) premarket notification submitted by O.R. Concepts, Inc. for the device "O.R. CONCEPTS' IRRIGATING KITTNER". The FDA issued a decision of Substantially Equivalent on April 7, 1993. The device falls under product code FGS (Carrier, Sponge, Endoscopic), a Class II device regulated under 21 CFR 876.1500. O.R. Concepts, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by O.R. Concepts, Inc.

  • K941337 — FLOWGUN ELECTROCAUTERY PROBES (August 17, 1994)
  • K935971 — FLOWGUN ELECTROCAUTERY PROBES (May 16, 1994)
  • K935970 — FLOWGUN ELECTROCAUTERY PROBE HANDLE (May 16, 1994)
  • K935645 — FLOWGUN REUSABLE IRRIGATION PROBES (March 7, 1994)
  • 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)

FDA data resources