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510(k) K921017

HARGIS SR2 SELF-RETRACTION SYSTEM by Medin Corp. — Product Code GAD

K921017 is an FDA 510(k) premarket notification submitted by Medin Corp. for the device "HARGIS SR2 SELF-RETRACTION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 2, 1993. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Medin Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1993
Date Received
March 3, 1992
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 Medin Corp.

  • K921020 — HARGIS SELF RETRACTION SYSTEM (July 2, 1993)
  • K921019 — HARGIS RECTAL SELF RETRATION SYSTEM (July 2, 1993)
  • K833343 — STERILIZATION CONTAINER (November 3, 1983)
  • K761032 — CRADLING SYSTEM (January 26, 1977)

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