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510(k) K140991

RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE by Ranfac, Corp. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2014
Date Received
April 17, 2014
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

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  • K031344 — RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE (May 23, 2003)
  • K012224 — SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW (August 22, 2001)
  • K961922 — RDP-2 (August 9, 1996)
  • K951090 — INTRODUCER (July 11, 1995)
  • K930474 — NEEDLE, PNEUMOPERITONEUM, SPRING LOADED (July 23, 1993)
  • K864139 — RANFAC CUT BIOPSY NEEDLE (November 5, 1986)

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