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510(k) K913248

CYTOLOGY BRUSH by Annex Medical, Inc. — Product Code FDX

K913248 is an FDA 510(k) premarket notification submitted by Annex Medical, Inc. for the device "CYTOLOGY BRUSH". The FDA issued a decision of Substantially Equivalent on September 30, 1991. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Annex Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1991
Date Received
July 22, 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 Annex Medical, Inc.

  • K954377 — FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC (October 26, 1995)
  • K952863 — FORCEPS, BIOPSY, NON-ELECTRIC (July 19, 1995)
  • K951532 — METAL URETERAL BASKET STONE DISLODGER (July 19, 1995)
  • K951761 — METEL URETERAL BASKET STONE DISLODGER (May 11, 1995)
  • K934636 — ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR (February 25, 1994)
  • K934598 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (January 7, 1994)
  • K934675 — METAL URETERAL BASKET STONE DISLODGER (January 7, 1994)
  • K925267 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (February 10, 1993)
  • K925559 — BILIARY STONE DISLODGER (December 17, 1992)
  • K921401 — BIOPSY FORCEPS (October 21, 1992)

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