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510(k) K844177

COSGROVE MITRAL VALVE RETRACTOR by Kapp Surgical Instrument, Inc. — Product Code GAD

K844177 is an FDA 510(k) premarket notification submitted by Kapp Surgical Instrument, Inc. for the device "COSGROVE MITRAL VALVE RETRACTOR". The FDA issued a decision of Substantially Equivalent on November 8, 1984. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Kapp Surgical Instrument, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1984
Date Received
October 25, 1984
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 Kapp Surgical Instrument, Inc.

  • K200289 — Michler-Kapp Cardiovascular Vent Catheter (January 28, 2021)
  • K072216 — KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 (November 9, 2007)
  • K050384 — KAPP BARI-RING, MODEL KS-BR-2005 (January 13, 2006)
  • K050655 — MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 (August 8, 2005)
  • K050657 — MONDEAL CONTOUR HO SYSTEM (August 8, 2005)
  • K033930 — KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (July 28, 2004)
  • K030237 — KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT (August 29, 2003)
  • K843368 — KAPP SPINAL BUTTON (September 12, 1984)

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