Home / 510(k) Clearances / K884819

510(k) K884819

O'NEIL URINARY CATHETER INTRODUCER by Medical Marketing Group — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1989
Date Received
November 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Medical Marketing Group

  • K910022 — MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT (April 2, 1991)
  • K874682 — MMG CATHETER PLUG W/DRAINAGE TUBE COVER (January 27, 1988)
  • K871999 — MMG URO-SELF CATHETER (August 25, 1987)
  • K863912 — THE MMG 5 IN 1 CONNECTOR (October 27, 1986)
  • K840838 — MMG CONNECTIVE TUBING (March 30, 1984)
  • K821168 — DISPOSABLE URINARY LEGBAG W/STRAP (May 24, 1982)
  • K811469 — MMG URINARY DRAINAGE TUBING (June 12, 1981)
  • K800694 — MMG DISPOSABLE URINARY LEG BAG (May 30, 1980)
  • K791847 — ASPRI-LUKE (October 2, 1979)
  • K790279 — CATHETER, MMG LATEX EXTERNAL (March 6, 1979)

Other clearances for product code KNY

  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)
  • K090121 — PRE-FILLED CATHETER INFLATION SYRINGE (April 15, 2009)