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510(k) K904434

SEXTON CYSTOTOMY URINE PUMP (SCUP2) by Phoenix Bioengineering, Inc. — Product Code KOB

K904434 is an FDA 510(k) premarket notification submitted by Phoenix Bioengineering, Inc. for the device "SEXTON CYSTOTOMY URINE PUMP (SCUP2)". The FDA issued a decision of Substantially Equivalent on February 1, 1991. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Phoenix Bioengineering, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1991
Date Received
September 28, 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 Phoenix Bioengineering, Inc.

  • K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES (December 30, 1993)
  • K913490 — PHOENIX BURR HOLE BUTTON, BURR 1 (January 13, 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