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510(k) K962144

PHOENIX ETE TISSUE EXTENSION SYSTEM by Phoenix Biomedical Corp. — Product Code MKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1997
Date Received
June 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Skin Closure
Device Class
Class I
Regulation Number
878.4320
Review Panel
SU
Submission Type

Other clearances by Phoenix Biomedical Corp.

  • K033017 — PHOENIX INFUSION CATHETER (April 7, 2004)
  • K030468 — ACURA ELITE GRAVITY COMPENSATING RESERVOIR (October 15, 2003)
  • K024101 — PHOENIX UNIVERSAL SHUNT SYSTEM (January 27, 2003)
  • K024040 — ACCURA ELITE SHUNT SYSTEM (January 27, 2003)
  • K021644 — PERF (OMMAYA STYLE) RESERVOIRS (August 6, 2002)
  • K002476 — LUMBOPERITONEAL SHUNT SYSTEM (November 9, 2000)
  • K000514 — RUMBAR DRAINAGE SYSTEM (May 10, 2000)
  • K991429 — DIAMOND II VALVE (May 19, 1999)
  • K990256 — CRX WORLD SHUNT (April 1, 1999)
  • K974096 — CRX DIAMOND VALVE (December 8, 1998)

Other clearances for product code MKY

  • K002315 — WISEBANDS SKIN CLOSURE DEVICE (March 15, 2001)
  • K982439 — PROXIDERM, MODELS TN 460, TN 90 460, BK 460 (September 8, 1998)
  • K970439 — PROXIDERM (D-460,D 90 460,D 180,460, PS 460) (April 16, 1997)
  • K942425 — PROXIDERM (TENTATIVE) (November 4, 1994)
  • K942526 — SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM (July 19, 1994)