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510(k) K915175

REDDICK RETRACTOR by Ideal Medical, Inc. — Product Code GAD

K915175 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "REDDICK RETRACTOR". The FDA issued a decision of Substantially Equivalent on April 29, 1992. The device falls under product code GAD (Retractor), 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
April 29, 1992
Date Received
November 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
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)
  • 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)
  • K911601 — REDDICK TROCAR AND CANNULA (May 21, 1991)

Other clearances for product code GAD

  • K152538 — JRP Wound Spreader (April 13, 2016)
  • K151104 — OTELO LL (January 6, 2016)
  • K132645 — THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (October 4, 2013)
  • K071775 — DASH (August 7, 2007)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (April 26, 2005)
  • K043602 — QUADRANT RETRACTOR SYSTEM (February 23, 2005)
  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
  • K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (August 18, 1998)
  • K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM (September 20, 1996)
  • K943875 — VILLALTA RETRACTOR (November 9, 1994)

FDA data resources