Home / 510(k) Clearances / K896425

510(k) K896425

PORGES CYTOLOGY BRUSHES by Porges Corp. — Product Code FDX

K896425 is an FDA 510(k) premarket notification submitted by Porges Corp. for the device "PORGES CYTOLOGY BRUSHES". The FDA issued a decision of Substantially Equivalent on January 29, 1990. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Porges Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1990
Date Received
November 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Cytology Brush
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To collect cells for cytological evaluation.

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)
  • K896505 — PORGES UNIVERSAL HANDLES (January 30, 1990)
  • K896507 — PORGES DIATHERMY SNARE (January 29, 1990)
  • K896504 — PORGES 2-WAY BALLOON EXTRACTION CATHETER (January 26, 1990)

Other clearances for product code FDX

  • K250993 — Single Use Cytology Brush V (BC-V600P-3010) (December 18, 2025)
  • K220063 — Single Use Cytology Brush (July 28, 2022)
  • K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (November 14, 2019)
  • K191485 — Deflectable Brush Biopsy Set (June 26, 2019)
  • K182231 — Brush Biopsy Set ; Deflectable Brush Biopsy Set (May 1, 2019)
  • K181317 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (February 8, 2019)
  • K172663 — Cytology Brush (March 5, 2018)
  • K171573 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (December 29, 2017)
  • K171607 — Bronchi and Gastrointestinal Cytology Brush (July 31, 2017)
  • K151889 — Infinity ERCP Sampling Device (July 30, 2015)

FDA data resources