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510(k) K021856

PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX by Porges S.A. — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2002
Date Received
June 6, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Porges S.A.

  • K013921 — PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X (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)
  • K896424 — PORGES SCLEROTHERAPY NEEDLES (January 26, 1990)

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  • K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (June 17, 2019)
  • K182122 — Ureteric Catheters (October 4, 2018)
  • K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Cathet (September 14, 2018)
  • K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric C (December 21, 2017)
  • K133750 — OCCLUDER OCCLUSION BALLOON CATHETER (January 8, 2014)
  • K092250 — MEDLINE RED RUBBER URETHRAL CATHETER (January 21, 2010)
  • K083788 — ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (March 3, 2009)