Home / 510(k) Clearances / K942002

510(k) K942002

RETRACTOR by Automated Medical Products Corp. — Product Code GAD

K942002 is an FDA 510(k) premarket notification submitted by Automated Medical Products Corp. for the device "RETRACTOR". The FDA issued a decision of Substantially Equivalent on May 17, 1994. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Automated Medical Products Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1994
Date Received
April 25, 1994
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 Corp.

  • K942910 — DEEPVISON (July 21, 1995)
  • K942818 — DEEP SUTURE (August 25, 1994)
  • K940199 — DISSECTOR (March 30, 1994)
  • K832827 — CORPULS 300 (November 3, 1983)
  • K792145 — AUTOMATIC RETRACTOR HOLDERS (December 5, 1979)

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