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510(k) K790952

CLAMP COVERS by Medi-Spec — Product Code GAD

K790952 is an FDA 510(k) premarket notification submitted by Medi-Spec for the device "CLAMP COVERS". The FDA issued a decision of Substantially Equivalent on June 5, 1979. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Medi-Spec has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1979
Date Received
May 22, 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 Medi-Spec

  • K833068 — LAMINARIA JAPONICA CERVICAL DILATOR (February 4, 1984)
  • K812694 — WHISK-R (October 26, 1981)
  • K812426 — UTERINE ASPIRATION CURETTES(RIGID&FLEX) (October 8, 1981)
  • K801554 — STERILE CAST PADDING (August 4, 1980)
  • K800404 — MEDSPEC OPERATIVE OPTHALMIC KIT (April 24, 1980)
  • K800490 — STERILE DRESSING PACK (March 12, 1980)
  • K780548 — DISPOSA-LOOPS (August 21, 1978)

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