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510(k) K896505

PORGES UNIVERSAL HANDLES by Porges Corp. — Product Code GCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1990
Date Received
November 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Ac-Powered And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Porges Corp.

  • K013921 — PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X (October 17, 2002)
  • 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)
  • K896507 — PORGES DIATHERMY SNARE (January 29, 1990)
  • K896425 — PORGES CYTOLOGY BRUSHES (January 29, 1990)
  • K896424 — PORGES SCLEROTHERAPY NEEDLES (January 26, 1990)

Other clearances for product code GCP

  • K954614 — EOS BRAND DISPOSABLE PROCTOSCOPE (April 10, 1996)
  • K896008 — MODEL 6500 MERCURY ARC LIGHT SOURCE (December 27, 1989)
  • K862424 — STEERABLE CATHETER SYSTEM (September 22, 1986)
  • K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE (February 12, 1986)
  • K843683 — MODULAR FIBERSCOPE SYSTEM (January 18, 1985)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K821999 — ENDOSCOPIC SCLEROTHERAPY BALLOON (August 27, 1982)
  • K801247 — CCD ENDOSCOPE AND ATTACHMENTS (July 28, 1980)
  • K790071 — ENDOSCOPE AND ACCESSORIES (April 2, 1979)
  • K771919 — FIBER OPTICS SIGMOIDOSCOPE (October 20, 1977)