Home / 510(k) Clearances / K942630

510(k) K942630

WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE by Mill-Rose Laboratory — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1994
Date Received
June 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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 KNW

  • K260365 — Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Ma (March 4, 2026)
  • K252795 — ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy De (February 23, 2026)
  • K252681 — EnCor EnCompass™ Breast Biopsy and Tissue Removal System (December 12, 2025)
  • K252183 — Resitu Slider 09 (RESL09) (September 24, 2025)
  • K243407 — Forcyte Autograft Harvest Kit (July 29, 2025)
  • K244018 — Disposable Biopsy Needle (July 22, 2025)
  • K243296 — Disposable Biopsy Needle (July 11, 2025)
  • K250032 — Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (July 10, 2025)
  • K243886 — ExpressCore Biopsy Device (April 29, 2025)
  • K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (April 24, 2025)