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510(k) K842748

SURGITEK RECONSTRUC-NIPPLE PROSTHESIS by Medical Engineering Corp.

K842748 is an FDA 510(k) premarket notification submitted by Medical Engineering Corp. for the device "SURGITEK RECONSTRUC-NIPPLE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on September 26, 1984. Medical Engineering Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1984
Date Received
July 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Medical Engineering Corp.

  • K934141 — STAND ALONE CYSTOMETROGRAM (November 18, 1993)
  • K905289 — SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT (March 13, 1991)
  • 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)
  • K832043 — SURGIKEK PENILE PROSTHESIS TAIL EXTEND (October 20, 1983)

FDA data resources