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510(k) K850152

PRECONNECTED URETHRAL CATHETER TRAY by Inmed Corp.

K850152 is an FDA 510(k) premarket notification submitted by Inmed Corp. for the device "PRECONNECTED URETHRAL CATHETER TRAY". The FDA issued a decision of Substantially Equivalent on March 12, 1985. Inmed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
January 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Inmed Corp.

  • K862672 — ESOPHAGEAL STETHOSCOPE WITH THERMISTOR (October 27, 1986)
  • K853162 — STERILE NASOPHARYNGEAL AIRWAY (August 6, 1985)
  • K850335 — URETEROSCOPY CATHETER (March 12, 1985)
  • K850248 — DISPOSABLE GUEDEL AIRWAY (March 12, 1985)
  • K844801 — ULTRA EXTERNAL CATHETER (January 15, 1985)
  • K842301 — DISPOSABLE LATEX BANDAGE (November 5, 1984)
  • K842866 — URETHRAL CATHETERIZATION TRAY (September 10, 1984)
  • K841040 — FOX POST NASAL BALLOON CATHETER (August 17, 1984)
  • K842865 — ESOPHAGEAL STETHOSCOPE (August 15, 1984)
  • K841037 — PENROSE DRAINS (April 25, 1984)

FDA data resources