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510(k) K905289

SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT by Medical Engineering Corp. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1991
Date Received
November 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

Other clearances by Medical Engineering Corp.

  • K934141 — STAND ALONE CYSTOMETROGRAM (November 18, 1993)
  • K903448 — SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER (January 14, 1991)
  • K902773 — SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET (July 16, 1990)
  • K884746 — SURGITEK FLAT T-SPAN (August 10, 1989)
  • K883274 — SURGITEK (R) UROFLOW SYSTEM (February 8, 1989)
  • K881736 — SURGITEK CO2 DELIVERY SYSTEM (August 11, 1988)
  • K880801 — SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 (May 26, 1988)
  • K880802 — SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 (May 26, 1988)
  • K842748 — SURGITEK RECONSTRUC-NIPPLE PROSTHESIS (September 26, 1984)
  • K832043 — SURGIKEK PENILE PROSTHESIS TAIL EXTEND (October 20, 1983)

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