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510(k) K883274

SURGITEK (R) UROFLOW SYSTEM by Medical Engineering Corp. — Product Code FFG

K883274 is an FDA 510(k) premarket notification submitted by Medical Engineering Corp. for the device "SURGITEK (R) UROFLOW SYSTEM". The FDA issued a decision of Substantially Equivalent on February 8, 1989. The device falls under product code FFG (Device, Urine Flow Rate Measuring, Non-Electrical, Disposable), a Class II device regulated under 21 CFR 876.1800. Medical Engineering Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1989
Date Received
August 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

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)
  • 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)

Other clearances for product code FFG

  • K893827 — PEAK FLOW RATE METER (August 11, 1989)
  • K850169 — ERIS URO-DIAGNOSTIC SYSTEM (April 22, 1985)
  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K843442 — URINARY DRAINAGE CONTAINER 2013 WITH (January 3, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K844030 — ACCUMETER ELECTRONIC URINEMETER SYSTEM (November 20, 1984)
  • K843224 — UROPUMP MODEL 1711 (October 19, 1984)
  • K833043 — UROMETER (February 4, 1984)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)
  • K813082 — UREOFIX 500 URINE MEASURING SYSTEM (December 31, 1981)

FDA data resources