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510(k) K881157

STERNUM SPREADER AND MITRAL VALVE RETRACTOR by T. Korossurgical Instruments Corp. — Product Code GAD

K881157 is an FDA 510(k) premarket notification submitted by T. Korossurgical Instruments Corp. for the device "STERNUM SPREADER AND MITRAL VALVE RETRACTOR". The FDA issued a decision of Substantially Equivalent on April 6, 1988. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. T. Korossurgical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1988
Date Received
March 18, 1988
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 T. Korossurgical Instruments Corp.

  • K001915 — GRAFT MARKER RING (April 27, 2001)
  • K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (December 4, 2000)
  • K954016 — VIDEOSCOPE W/IRRIGATION SHEATH (January 25, 1996)
  • K953998 — DISCETOME TISSUE ASPIRATOR (December 4, 1995)
  • K954014 — PERCUTANEOUS DISCECTOMY CANNULA SYSTEM (November 6, 1995)
  • K954052 — ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES (November 6, 1995)
  • K935529 — CERVICAL SELF-RETAINING RETRACTOR (March 22, 1994)
  • K926585 — THOROCOSCOPY SELF-RETAINING RETRACTOR (August 6, 1993)
  • K931262 — REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR (August 6, 1993)
  • K926583 — REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR (August 6, 1993)

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