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510(k) K981611

SNAP-N-PEEL INTRODUCERS by Circon Corp. — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1998
Date Received
May 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Circon Corp.

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  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K980972 — RIGID CULDOSCOPE AND ACCESSORIES (June 12, 1998)
  • K973820 — USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECT (May 12, 1998)
  • K964594 — VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VA (August 15, 1997)

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  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
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  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
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  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)