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510(k) K954745

MILL-ROSE RIGID SCOPE CLEANING BRUSHES by Mill-Rose Laboratory — Product Code FEB

K954745 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "MILL-ROSE RIGID SCOPE CLEANING BRUSHES". The FDA issued a decision of Substantially Equivalent on November 27, 1995. The device falls under product code FEB (Accessories, Cleaning, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1995
Date Received
October 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Cleaning, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
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)
  • K951051 — RITE-BITE BIOPSY FORCEPS (March 24, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)
  • K946293 — MILL-ROSE SCOPE CLEANING BRUSH (February 16, 1995)

Other clearances for product code FEB

  • K241168 — System 83 Revolve Endoscope Washer/Disinfector (December 19, 2024)
  • K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (December 2, 2024)
  • K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (June 30, 2023)
  • K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid (January 14, 2022)
  • K201920 — Endoscope Reprocessor OER-Elite (September 1, 2020)
  • K173590 — System 83 Plus Washer/Disinfector (March 30, 2020)
  • K190969 — ENDOSCOPE REPROCESSOR OER-Elite (July 9, 2019)
  • K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (April 23, 2019)
  • K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System (December 14, 2018)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)

FDA data resources