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510(k) K834402

GASTROINTESTINAL SHEATH BRUSH by Hobbs Medical, Inc. — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
December 14, 1983
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 Hobbs Medical, Inc.

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  • K182927 — Pulmonary Cytology Brush (February 7, 2020)
  • K093079 — TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, (August 2, 2010)
  • K030765 — HOBBS MISTIFIER SPRAY CATHETER (June 9, 2003)
  • K933354 — HOBBS MEDICAL CLEANING BRUSH (October 28, 1993)
  • K922396 — FUJINON FORCEPS -- MODIFICATION (December 10, 1992)
  • K921026 — PRESSURE GAUGE (April 24, 1992)
  • K914358 — ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP (November 19, 1991)
  • K893729 — HOBBS MEDICAL MICROBIOLOGY BRUSH (August 28, 1989)
  • K872509 — LINDEN STONE EXTRACTION BALLOON (September 22, 1987)

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)