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510(k) K952187

RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE by Rusch, Inc. — Product Code KOB

K952187 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE". The FDA issued a decision of Substantially Equivalent on July 25, 1995. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Rusch, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1995
Date Received
May 9, 1995
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 Rusch, Inc.

  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K993528 — RUSCH EMERGENCY MASK (May 31, 2000)
  • K993194 — RUSCH MANUAL RESUSCITATOR BAG (March 24, 2000)
  • K980870 — RUSCH SILICONE FOLEY CATHETER (June 9, 1998)
  • K974419 — RUSCH SIMPLASTIC COUNCILL TIP CATHETER (January 27, 1998)
  • K963779 — RUSCH ENTERAL FEEDING TUBE (May 23, 1997)
  • K970021 — RUSCH SUPRAPUBIC TRAY (February 7, 1997)
  • K963993 — RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET (December 17, 1996)
  • K955564 — RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE (June 28, 1996)
  • K955495 — RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE (June 27, 1996)

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)
  • K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SET (January 17, 2014)
  • 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)

FDA data resources