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510(k) K911601

REDDICK TROCAR AND CANNULA by Ideal Medical, Inc. — Product Code FSM

K911601 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "REDDICK TROCAR AND CANNULA". The FDA issued a decision of Substantially Equivalent on May 21, 1991. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Ideal Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1991
Date Received
April 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ideal Medical, Inc.

  • K944067 — PEANUT WAND, MODIFICATION (December 8, 1994)
  • K931115 — HATCHER STONE-EMBOLIS EXTRACTOR (August 20, 1993)
  • K926335 — IDEAS PEANUT WAND (June 24, 1993)
  • K922161 — GRICE SOFT TISSUE BIOPSY KIT (October 13, 1992)
  • K921922 — GRICE LAPAROSCOPIC SUTURING NEEDLE (July 8, 1992)
  • K915175 — REDDICK RETRACTOR (April 29, 1992)
  • K914880 — DUAL BALLOON EMBOLECTOMY CATHETER (March 16, 1992)
  • K913602 — IDEAS' PORT (January 2, 1992)
  • K914913 — GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST (December 31, 1991)
  • K912540 — CONTOUR-PORT (August 23, 1991)

Other clearances for product code FSM

  • K971217 — INSTRUMENT TRAY LINER (May 6, 1997)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K944025 — SURGICAL INSTRUMENT TRAY (November 22, 1994)
  • K912106 — ARTHROSCOPY TRAY (August 29, 1991)
  • K912053 — OPEN HEART TRAY (August 26, 1991)
  • K912052 — HEART CATH TRAY (August 20, 1991)
  • K912104 — MAJOR BASIN TRAY (August 9, 1991)
  • K910570 — SPLINTER TWEEZERS (May 31, 1991)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)
  • K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)

FDA data resources