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510(k) K001339

MRI FASTSYSTEM RETRACTOR SYSTEM by Omni-Tract Surgical, Div. Minn. Scientific, Inc. — Product Code GAD

K001339 is an FDA 510(k) premarket notification submitted by Omni-Tract Surgical, Div. Minn. Scientific, Inc. for the device "MRI FASTSYSTEM RETRACTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on May 17, 2000. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Omni-Tract Surgical, Div. Minn. Scientific, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2000
Date Received
April 27, 2000
Clearance Type
Special
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 Omni-Tract Surgical, Div. Minn. Scientific, Inc.

  • K992583 — MASS (MICRO-ACCESS SPINE SYSTEM) (October 29, 1999)
  • K950214 — ABDOMINAL WALL RETRACTOR (February 6, 1995)
  • K913803 — INTRALUMINAL ARTERY STRIPPER (April 24, 1992)

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)
  • 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)
  • K942002 — RETRACTOR (May 17, 1994)

FDA data resources