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510(k) K132890

SUPRAPUBIC CATHETER AND INTRODUCER SET by Mediplus , Ltd. — Product Code KOB

K132890 is an FDA 510(k) premarket notification submitted by Mediplus , Ltd. for the device "SUPRAPUBIC CATHETER AND INTRODUCER SET". The FDA issued a decision of Substantially Equivalent on January 17, 2014. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Mediplus , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2014
Date Received
September 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Suprapubic (And Accessories)
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

Other clearances by Mediplus , Ltd.

  • K131339 — CAPNOMASK (November 25, 2013)
  • K031617 — MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER (January 16, 2004)
  • K013704 — MEDIPLUS SINGLE USE GI MANOMETRY CATHETER (August 5, 2002)

Other clearances for product code KOB

  • K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set (November 1, 2024)
  • K181097 — Cook Cystostomy Catheter Set (January 18, 2019)
  • K182709 — One-Step Suprapubic Introducer (December 26, 2018)
  • K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (October 30, 2018)
  • K120127 — SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SY (October 26, 2012)
  • K014002 — ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (March 4, 2002)
  • K012153 — LOWSLEY SUPRAPUBIC TRACTOR (September 19, 2001)
  • K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (April 23, 1997)
  • K970021 — RUSCH SUPRAPUBIC TRAY (February 7, 1997)
  • K945480 — MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (August 28, 1995)

FDA data resources