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510(k) K071775

DASH by Ezsurgical — Product Code GAD

K071775 is an FDA 510(k) premarket notification submitted by Ezsurgical for the device "DASH". The FDA issued a decision of Substantially Equivalent on August 7, 2007. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Ezsurgical has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2007
Date Received
June 29, 2007
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 Ezsurgical

  • K082291 — A-LAP SET (A-LAP, EZAXESS, TROCAR) (January 2, 2009)

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

FDA data resources