Home / 510(k) Clearances / K852083

510(k) K852083

THE KENDALL URINARY OUTPUT MONITOR by The Kendal Co. — Product Code FFO

K852083 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "THE KENDALL URINARY OUTPUT MONITOR". The FDA issued a decision of Substantially Equivalent on September 20, 1985. The device falls under product code FFO (Retractor, Self-Retaining), a Class I device regulated under 21 CFR 876.4730. The Kendal Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1985
Date Received
May 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by The Kendal Co.

  • K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR (March 17, 2000)
  • K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY C (September 28, 1999)
  • K991758 — MONOJECT INSULIN SYRINGE (June 14, 1999)
  • K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (April 23, 1997)
  • K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP (April 25, 1995)
  • K942664 — KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM (January 17, 1995)
  • K942774 — POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING (July 20, 1994)
  • K892434 — KENDALL CURITY OXYGEN MASK (August 15, 1989)
  • K892438 — KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES (July 24, 1989)
  • K892440 — KENDALL CURITY EXTENSION TUBES (July 24, 1989)

Other clearances for product code FFO

  • K993544 — SPACE-OR RETRACTOR (December 22, 1999)
  • K870897 — KODNER ANAL PERIONEAL RETRACTOR (June 4, 1987)
  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)
  • K853119 — URODYN 1000 (October 4, 1985)

FDA data resources