Home / 510(k) Clearances / K841037

510(k) K841037

PENROSE DRAINS by Inmed Corp.

K841037 is an FDA 510(k) premarket notification submitted by Inmed Corp. for the device "PENROSE DRAINS". The FDA issued a decision of Substantially Equivalent on April 25, 1984. Inmed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
March 12, 1984
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)
  • K850248 — DISPOSABLE GUEDEL AIRWAY (March 12, 1985)
  • K850335 — URETEROSCOPY CATHETER (March 12, 1985)
  • K850152 — PRECONNECTED URETHRAL CATHETER TRAY (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)

FDA data resources