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510(k) K901603

MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER by Bivona Medical Technologies — Product Code KOB

K901603 is an FDA 510(k) premarket notification submitted by Bivona Medical Technologies for the device "MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER". The FDA issued a decision of Substantially Equivalent on May 4, 1990. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Bivona Medical Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1990
Date Received
March 27, 1990
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 Bivona Medical Technologies

  • K952700 — SUPERSLICK (October 31, 1995)
  • K942025 — BURGET NASAL STENT (October 27, 1995)
  • K944178 — BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES (October 27, 1994)
  • K935053 — BIVONA NASAL TURBINATE STENT (July 1, 1994)
  • K933398 — BIVONA ILLUMINATED ENDOTRACHEAL TUBE (October 6, 1993)
  • K931749 — BIVONA(R) ICU ENDOTRACHEAL TUBE (August 10, 1993)
  • K922665 — BIVONA HYPERFLEX TRACHEOSTOMY TUBE (January 7, 1993)
  • K923878 — BIVONA CUSTOMIZED TRACHEOSTOMY TUBES (December 29, 1992)
  • K920604 — BIVONA TRACHEAL T-TUBE STENT (July 27, 1992)
  • K915761 — BIVONA-COLORADO VOICE PROSTHESIS (June 29, 1992)

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