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510(k) K820771

MICROBIOLOGY SPECIMEN BRUSH by Mill-Rose Laboratory — Product Code BTG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1982
Date Received
March 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Biopsy, Bronchoscope (Non-Rigid)
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Mill-Rose Laboratory

  • K983124 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDUR (October 30, 1998)
  • K983122 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOL (October 30, 1998)
  • K971275 — MILL-ROSE DISPOSABLE POLYPECTOMY SNARE (May 23, 1997)
  • K962736 — MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE (July 29, 1996)
  • K960880 — MILL-ROSE BLIND MICROBIOLOGY BRUSH (April 29, 1996)
  • K954519 — WANG TRANSENDOSCOPIC ASPIRATION NEEDLE (December 22, 1995)
  • K951600 — MILL-ROSE ROTATABLE POLYPECTOMY SNARE (December 18, 1995)
  • K954745 — MILL-ROSE RIGID SCOPE CLEANING BRUSHES (November 27, 1995)
  • K951051 — RITE-BITE BIOPSY FORCEPS (March 24, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)

Other clearances for product code BTG

  • K251279 — Disposable Cytology Brush BC-202D/203D Series (June 12, 2025)
  • K182927 — Pulmonary Cytology Brush (February 7, 2020)
  • K190293 — Single Use Cytology Brush BC-205D (August 2, 2019)
  • K130357 — SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH (November 6, 2013)
  • K780872 — CYTOLOGY BRUSH (September 7, 1978)