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510(k) K914504

CYTOLOGY BRUSH by Surgitek Medical Engineering Corp. — Product Code FDX

K914504 is an FDA 510(k) premarket notification submitted by Surgitek Medical Engineering Corp. for the device "CYTOLOGY BRUSH". The FDA issued a decision of Substantially Equivalent on February 18, 1992. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Surgitek Medical Engineering Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1992
Date Received
October 9, 1991
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 Surgitek Medical Engineering Corp.

  • K914495 — E.R.C.P. CATHETER (January 30, 1992)
  • K914497 — BIOPSY FORCEPS (January 3, 1992)
  • K914505 — STONE BASKET (December 9, 1991)
  • K914503 — GRASPING FORCEPS (December 5, 1991)
  • K914496 — SCLEROTHERAPY NEEDLE (December 5, 1991)
  • K913928 — SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT (November 19, 1991)
  • K913294 — SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT (October 4, 1991)
  • K910769 — SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM (June 25, 1991)
  • K910768 — SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE (March 19, 1991)
  • K903127 — SURGITEK(R) TURP MONITOR (October 9, 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