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510(k) K845038

BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT by Ranfac, Corp. — Product Code GDF

K845038 is an FDA 510(k) premarket notification submitted by Ranfac, Corp. for the device "BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT". The FDA issued a decision of Substantially Equivalent on March 11, 1985. The device falls under product code GDF (Guide, Needle, Surgical), a Class I device regulated under 21 CFR 878.4800. Ranfac, Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1985
Date Received
December 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Needle, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ranfac, Corp.

  • K162932 — Ranfac Fat Aspiration Cannula (January 19, 2017)
  • K150156 — Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspirat (October 19, 2015)
  • K150563 — Marrow Cellution Bone Marrow Aspiration Needle (May 22, 2015)
  • K140991 — RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE (September 11, 2014)
  • K131157 — RANFAC BONE MARROW ASPIRATION NEEDLE (October 22, 2013)
  • 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)

Other clearances for product code GDF

  • K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001 (July 23, 2003)
  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)
  • K950007 — SURGICAL INSTRUMENT GUIDE (March 15, 1995)
  • K945124 — BREAST LESION LOCALIZATION NEEDLE (November 22, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K923840 — NEEDLE-GRABBER (July 13, 1993)
  • K923835 — THE ELEVENTH FINGER (July 9, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)

FDA data resources