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510(k) K792145

AUTOMATIC RETRACTOR HOLDERS by Automated Medical Products, Inc. — Product Code GAD

K792145 is an FDA 510(k) premarket notification submitted by Automated Medical Products, Inc. for the device "AUTOMATIC RETRACTOR HOLDERS". The FDA issued a decision of Substantially Equivalent on December 5, 1979. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Automated Medical Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1979
Date Received
October 23, 1979
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 Automated Medical Products, Inc.

  • K942910 — DEEPVISON (July 21, 1995)
  • K942818 — DEEP SUTURE (August 25, 1994)
  • K942002 — RETRACTOR (May 17, 1994)
  • K940199 — DISSECTOR (March 30, 1994)
  • K832827 — CORPULS 300 (November 3, 1983)

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