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510(k) K915762

POOLE TIP SUCTION PROBE by O.R. Concepts, Inc. — Product Code GCI

K915762 is an FDA 510(k) premarket notification submitted by O.R. Concepts, Inc. for the device "POOLE TIP SUCTION PROBE". The FDA issued a decision of Substantially Equivalent on March 13, 1992. The device falls under product code GCI (Laryngoscope, Endoscope), 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
March 13, 1992
Date Received
December 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Endoscope
Device Class
Class II
Regulation Number
876.1500
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 GCI

  • K021747 — DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (August 15, 2002)
  • K003222 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (November 3, 2000)
  • K001362 — KARL STORZ 3D VIDEO SYSTEM (July 17, 2000)
  • K933515 — BOOTY ENDOSCOPE WARMER (October 27, 1993)
  • K930302 — BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (October 27, 1993)
  • K930496 — GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (April 20, 1993)
  • K922123 — AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH (February 1, 1993)
  • K920139 — GLEESON CLOT-BUSTER (April 15, 1992)
  • K914120 — SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (October 30, 1991)
  • K911829 — ENDOSTAPLE (August 28, 1991)

FDA data resources