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510(k) K923908

# 9455 AND #9457 POOLE TIP SUCTION PROBE by O.R. Concepts, Inc. — Product Code GCY

K923908 is an FDA 510(k) premarket notification submitted by O.R. Concepts, Inc. for the device "# 9455 AND #9457 POOLE TIP SUCTION PROBE". The FDA issued a decision of Substantially Equivalent on May 17, 1993. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. O.R. Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1993
Date Received
August 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type

Other clearances by O.R. Concepts, Inc.

  • K941337 — FLOWGUN ELECTROCAUTERY PROBES (August 17, 1994)
  • K935970 — FLOWGUN ELECTROCAUTERY PROBE HANDLE (May 16, 1994)
  • K935971 — FLOWGUN ELECTROCAUTERY PROBES (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 GCY

  • K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM (October 1, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)

FDA data resources