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510(k) K881097

SPEC 5* SUPRAPUBIC CATHETER by Porges Corp. — Product Code KOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1988
Date Received
March 15, 1988
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 Porges Corp.

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  • K021856 — PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, (October 17, 2002)
  • K013174 — PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMAL (January 4, 2002)
  • K013172 — PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, (December 20, 2001)
  • K900269 — PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE (July 3, 1990)
  • K900031 — MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS (March 6, 1990)
  • K896503 — PORGES ERCP CATHETERS (January 30, 1990)
  • K896505 — PORGES UNIVERSAL HANDLES (January 30, 1990)
  • K896507 — PORGES DIATHERMY SNARE (January 29, 1990)
  • K896425 — PORGES CYTOLOGY BRUSHES (January 29, 1990)

Other clearances for product code KOB

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  • 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)